Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary:

As a key member of the cross-functional Development Team responsible for providing regulatory writing expertise and leadership to formulate the writing strategy for key regulatory documents for submission. The Sr. Director, Head of Regulatory & Medical Writing will be responsible for providing guidance to the medical and or regulatory writing group (contractors and internal writers) assigned to deliverables and ensuring appropriate work allocation and document preparation.; will also provide review and substantive editing of documents to ensure delivery of high-quality documents. This individual will work effectively with many other functional groups, including with Clinical Scientist(s), Medical Monitors, Regulatory and other functions as applicable, and collaborate with clinical medical writing as applicable to ensure scientific excellence in the execution of clinical trials. The Head of Regulatory Writing will build a medical writing group internally when appropriate.

Reporting to the SVP, Head of Regulatory Affairs, this role will be responsible for the regulatory writing & medical writing deliverables of assigned project(s), in accordance with the agreed timelines and quality standards.

Responsibilities:

• Ensure appropriate allocation of internal and external resources needed for all regulatory writing deliverables.
• Hire and manage medical writers internally and manage external medical writing contractors.
• Forecasting and maintaining budget for the regulatory writing team.
• Assess efficiencies, help identify areas of improvement and initiate improvement processes.
• Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to:
• Clinical study protocols and clinical protocol amendments (in partnership with Clinical Science/Clinical Development)
• Clinical study reports
• Investigator’s brochures and annual updates
• IND submissions and annual reports
• Lay-person summary
• Integrated summary reports
• Clinical, Nonclinical and Multidisciplinary Information Amendments
• NDA, BLA, MAA, (e)CTD submissions
• Risk Management Plans
• Health Authority responses
• Briefing Documents, ODDs, BTDs/PRIME, FTD etc
• Participate in relevant subteam(s) and ensure effective planning and management of timelines for all components of assigned documents across all projects.
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• Support and develop deliverables required for global transparency and disclosure requirements (e.g., plain language lay summary, applicable redactions to regulatory documents subject to EU posting regulations and results for EU CTR).Partner with Biometrics in developing standard TFLs and in text tables for deliverables as applicable
• Maintain and support developing and reviewing standard processes and templates.
• Review and edit documents as required.
• Work effectively and lead in cross-functional working groups.

Qualifications:

• Candidates must have a BS with 15+ years, or MS or other advanced science degree (e.g.: RN, NP, MSN, PharmD, PhD, MD) with 10+ years of experience in oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical/biotech industry.
• Prior experience leading a regulatory writing group
• Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA).
• Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, document management systems.
• Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures and clinical study data collection and results reporting.
• Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Experience writing, at a minimum, protocols (Phase 1-3, in oncology), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Pediatric Investigational Plans (PIPs) is preferred.
• Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize complex tabular and graphical data presentations.
• Strong organization, documentation and communication skills with an ability to multitask.
• Adaptable / flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

Position Title:  

Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary:

Nurix Therapeutics, Inc. is seeking a Manager/Sr. Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team.  The successful candidate will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products for guiding and executing upon regulatory strategy of compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. This includes supporting regulatory activities to enable clinical development plans and studies, working cross-functionally across the organization.

Responsibilities:

• Provides regulatory strategic direction and support for assigned global development programs/development program activities
• Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
• Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
• Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
• Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
• Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
• Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
• Assist in the cataloging and maintenance of regulatory application submissions
• Conduct research and stay up-to-date on regulatory requirements and changes
• Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
• Monitor and assess regulatory risks and develop mitigation strategies
• Oversee quality assurance processes to ensure compliance with regulatory standards
• Review SOPs pertaining to Regulatory
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
• Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed

Experience and Skills:

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 8 years in Regulatory affairs strategy
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
• Ability to read, analyze and interpret scientific and technical information, as well as regulatory
• Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external
• Ability to comply with changing regulatory
• Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
• Strong project management and critical thinking skills
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

Summary:

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations.  

Essential Functions:

• Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies
• Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance
• Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
• Provides CMC regulatory guidance to cross-functional teams and key stakeholders
• Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development
• Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
• Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
• Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
• Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

Requirements:

Bachelor’s Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience. Other combinations of education and/or experience may be considered.

• Prior experience preparing/authoring CMC DS sections:
• BLA highly preferred.
• Post-approval supplements/variations highly preferred.
• INDs/IMPDs.
• Prior development or manufacturing experience is a plus.
• Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent interpersonal skills to communicate difficult concepts.

• Strategic thinking and strong problem-solving skills
• Collaborates and communicates in an open, clear, complete, timely, and consistent manner
• Strong sense of planning and prioritization, and the ability to work with all levels of management
• Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines

The Opportunity:

This newly created role represents a unique opportunity to shape the future of patient engagement at Revolution Medicines. The Omnichannel Strategy & Operations Team is seeking a forward-thinking, digitally fluent marketing leader to drive patient non-personal promotion (NPP) across our oncology portfolio.

The Senior Manager, Omnichannel Marketing (Portfolio Patient NPP) will lead the design and execution of innovative patient omnichannel capabilities and campaigns that support brands and disease state education. The Senior Manager will oversee the creation and management of omnichannel-ready content derivatives—ensuring cohesive, high-impact patient engagement across channels.  This role also offers the opportunity to build and scale best-in-class digital engagement models in close partnership with our Brand Patient Leads, Insights, and IT teams.

In addition to leading campaign execution, this individual will partner to identify measurement opportunity, optimize performance through data-driven insights, and identify emerging digital technologies that accelerate market readiness and enhance the patient experience.

Note: Branded & Unbranded Patient Marketing strategy, imperatives, objectives & content will be created by the brand aligned Patient Marketing Business Lead.

Key Responsibilities:

• Lead the Patient Non-Personal Promotion (NPP) Omnichannel Operations across oncology launches while identifying & designing integrated omnichannel engagement opportunities aligned to patient journey insights and brand objectives.

• Partner with Patient Marketing Business Lead(s) to understand the Patient engagement Strategy, Objectives and market research (per Asset/Tumor)

• Translate brand objectives and market research into engaging and effective Patient NPP campaigns to meet patients’ needs and preferences while ensuring consistent messaging across multiple channels.

• Develop and execute comprehensive Patient NPP marketing plan for all oncology launch products and indications, including creating strategic proposals and actionable options for effectively targeting patients. For example, what is the approach, channel, optimal media usage & measurement?

• Leverage existing or derivative assets.

• This includes vendor management to achieve transparent & optimal performance.

• Analyze and interpret Patient NPP campaign performance data to derive actionable insights and optimize future NPP initiatives.

• Partnering with the Insights team, present marketing performance insights and recommendations to Commercial Leadership Team.

• Collaboratively work with cross functional omnichannel partners to think strategically to solve/impact key business solutions/opportunities and present these complex ideas with clarity. For example: what hypothesis should we be testing for patients to engage more optimally? Specifically- Channels, Tactics, Orchestration, Impact/Measure, Cos

• Offer targeted digital solutions and strategies to enhance Patient, NPP, product & Disease State education launch strategies and reach the right patients/caregivers.

• Identify and evaluate new marketing technology platforms that support future readiness and patient engagement models.

• NPP Content Owner the PRC weekly team to manage & move assets from creation to execution as needed for NPP channels.

• Collaborate closely with cross-functional stakeholders (Medical Affairs, Market Access, Commercial, Legal) to ensure alignment of Patient NPP brand strategy and execution is compliant.

• Manage Patient NPP Omnichannel tactics marketing budgets effectively to ensure efficient resource allocation.

Required Skills, Experience and Education:

• Bachelor’s degree required; MBA or advanced degree strongly preferred.

• Minimum of 6-8 years of progressive experience in marketing within the pharmaceutical or biotech industry, including oncology product experience.

• Demonstrated examples of experience in Digital Marketing, Media Channel Marketing or Personal Promotion Marketing experience.

• Track record of being a collaborative team player, building positive partnerships, and adaptive to meet the needs of a growing business.

• Experience managing external vendors, budgets, and promotional reviews in a regulated environment

• Strong analytical skills and ability to interpret complex datasets to drive marketing decisions.

• Proven ability to influence cross-functional teams and stakeholders without direct authority.

• Strong analytical skills and ability to interpret complex datasets to drive marketing decisions.

• Thorough knowledge of current digital marketing platforms, media channels, and regulatory considerations.

Preferred Skills:

• Experience launching targeted oncology therapies or rare disease products.

• Experience optimizing Branded & Unbranded Patient NPP channels and/or journeys.

• Familiarity with modular content management, dynamic content creation, or AI-enhanced promotional tools.

• Experience in a high-growth, pre-commercial environment. 

  #LI-Hybrid  #LI-SS2

Who We Are

Weber Shandwick is more than a leading global PR agency – we’re an engagement agency and we’re working in and around the cutting edge of the new media landscape. We’re storytellers, content creators, and we engage people IN the story. Our success is built on a deep commitment to client service and to our people. We embrace creativity and collaboration, and we engage stakeholders in new and creative ways to build brands and reputations.

Senior Vice President, Client Experience, Corporate Health

About Weber Shandwick Healthcare

Weber Shandwick partners with leading healthcare companies to address critical health challenges through innovative, award-winning communications strategies. Our success stems from our collaborative culture, deep scientific expertise, and integrated capabilities—supported by our global network and driven by exceptional talent.

About the Role

We're seeking an accomplished healthcare communications leader to serve as a strategic partner leading clients, new business efforts and operations as part of the Boston Health team leadership. This critical role combines senior client leadership with hands-on execution for corporate healthcare and corporate health social assignments.

You will be a trusted advisor and operational leader who:

• Serves as the primary day-to-day strategist and relationship manager for key corporate healthcare clients
• Leads and scales our corporate health social media practice with strategic vision and execution excellence
• Manages complex, integrated teams with commercial acumen and efficiency
• Balances big-picture thinking with meticulous attention to detail
• Demonstrates the professional maturity and judgment

This is an opportunity to shape the future of corporate healthcare communications with clients and our agency while partnering with senior leaders and great thinkers in Boston and across our network.

Key Responsibilities

Client Leadership & Business Growth

• Own day-to-day client relationships and serve as the trusted strategic counsel on corporate healthcare communications assignments
• Drive client satisfaction and organic growth by anticipating needs and delivering innovative solutions
• Lead new business development efforts, from pitch strategy to presentation
• Manage the commercial aspects of large accounts, including budgets, resources, and profitability

Corporate Healthcare & Social Media Expertise

• Develop and execute integrated corporate communications strategies that address business challenges in healthcare's evolving landscape (policy, reputation, stakeholder engagement, issues management)
• Lead corporate health social media strategy and execution, staying ahead of platform innovations and best practices
• Navigate the intersection of corporate affairs, regulatory environment, and digital communications
• Provide thought leadership on emerging trends in the corporate health space and stay ahead of shifts in healthcare corporate affairs, media landscape, and communications technology

Team Leadership & Development

• Build, mentor, and inspire high-performing teams across offices and disciplines
• Coach team members to achieve their professional goals while maintaining quality standards
• Deploy teams strategically to maximize efficiency and impact
• Foster a culture of collaboration, curiosity, and continuous improvement

Required Qualifications

• Bachelor's degree
• 10+ years of progressive healthcare communications experience, including substantial agency background
• Proven expertise in corporate healthcare communications (corporate reputation, issues management, executive visibility, stakeholder engagement)
• Demonstrated leadership in healthcare social media strategy and execution
• Track record managing large pharmaceutical or healthcare accounts with complex, multi-market teams
• Deep understanding of the pharmaceutical/healthcare landscape and corporate affairs environment
• Excellence in client relationship management with ability to operate independently with senior client stakeholders
• Strong commercial acumen
• Exceptional written, verbal, and presentation skills
• Proven ability to lead, develop, and retain talent
• Proficiency in MS Office; advanced skills in PowerPoint and presentation platforms

What Sets You Apart

• Professional maturity and judgment to navigate complex situations independently
• Results-driven mindset with focus on measurable outcomes
• Entrepreneurial spirit combined with collaborative leadership style
• Culture champion who leads by example and inspires teams

Salary Range: $171,000 USD – $230,000 USD

Where an employee or prospective employee is paid within this range will depend on, among other factors, actual ranges for current/former employees in the subject position; market considerations; budgetary considerations; tenure and standing with the company (applicable to current employees); as well as the employee’s/applicant’s background, pertinent experience, and qualifications.

Weber Shandwick is proud to be an Equal Opportunity/Affirmative Action employer. Weber Shandwick recruits qualified applicants without regard to race, color, religion, gender, age, ethnic or national origin, protected veteran status, physical or mental disability, sexual orientation, gender identity, marital status or citizenship status.

#LI-GH

Legend Biotech is seeking an Executive Director, Pipeline Clinical Lead as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Pipeline Clinical Lead is a senior clinical development leader accountable for the scientific and medical direction of early stage clinical programs. This role provides strategic and operational leadership across first in human through proof of concept studies, with accountability for clinical strategy, trial design, execution, interpretation, and regulatory interactions.

The Pipeline Clinical Lead will lead and develop a team of physicians and scientists, work closely with cross functional partners, and collaborate with external development partners and investigators. Deep expertise in clinical trial design, regulatory frameworks, and compliance in drug development—ideally within cell therapy—is essential.

This role requires strong scientific judgment, leadership presence, and a hands on approach in a fast paced, entrepreneurial environment, with a clear focus on patient safety and clinical impact.

Key Responsibilities

Clinical Development Leadership

• Serve as clinical science lead for early stage programs (pre IND through Phase 1/2), including study design, execution, data interpretation, and reporting.
• Define and integrate clinical strategies, including PK/PD, biomarkers, diagnostics, and translational approaches, particularly for cell and gene therapies.
• Provide clinical input into asset selection, review of preclinical data, and development path decisions.

Regulatory & Compliance

• Lead or support IND preparation and amendments, clinical sections of regulatory submissions, and responses to health authority questions.
• Represent the clinical function in pre IND, IND, and (as applicable) BLA/MAA interactions with regulatory agencies.
• Champion patient safety, ethical conduct, and compliance with GCP, corporate policies, and global healthcare regulations.

Cross Functional & External Collaboration

• Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Early Discovery,
• Manufacturing, Biomarkers, and Pharmacovigilance to ensure integrated program delivery.
• Collaborate with external development partners, academic investigators, KOLs, and study sites.
• Act as a credible scientific and clinical representative for programs in internal governance and external forums.

People & Matrix Leadership

• Provide direct line management and mentorship for Medical Directors, Clinical Research Scientists, Medical Writing, Clinical Program management and other clinical staff as applicable.
• Lead effectively in a matrix environment, anticipating cross functional needs and proactively resolving conflicts or risks.
• Contribute clinical leadership to business development, due diligence, and partnership activities when required.

Requirements

• MD or MD PhD (or equivalent) with US board certification or international equivalent.
• ≥8 years of clinical development experience in industry and/or academia, with demonstrated leadership in hematology/oncology.
• Proven experience designing and executing clinical trials from first in human through registrational stages.
• Prior involvement with IND submissions; experience with BLA/MAA filings and health authority meetings strongly preferred.
• Cell therapy and/or CAR T clinical development experience highly desirable IT Skills.
• Strong scientific judgment with the ability to navigate complex clinical and regulatory challenges.
• Demonstrated ability to lead cross functional and geographically distributed teams in a matrix environment.
• Excellent written and oral communication skills, including protocol writing, regulatory documents, publications, and senior level presentations.
• Highly collaborative, influential leader with the ability to represent programs with credibility and confidence.
• Hands on, execution oriented mindset with strong organizational and analytical skills.
• Willingness to travel up to 15–20%.

#Li-AS1

#Li-Hybrid

Legend Biotech is seeking a Sr. Director, Clinical Operations Capabilities and Standards as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sr. Director, Clinical Operations Capabilities and Standards will be responsible for providing strategic leadership and oversight for foundational and centralized trial operations support towards cost-effective scalability of the Clinical Operations department. 

Among other responsibilities, this position will establish, oversee and grow Clinical Operations capability pillars that include Clinical Trial Planning and Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations; including managing and developing staff within each pillar.

This position will also be the company subject-matter expert for clinical operations standards applied across the portfolio of Legend IND clinical trials.

Key Responsibilities

Oversee the development and strengthening of the following clinical operations capabilities and functions, with leads/teams in each of these areas:

Clinical Trial Planning & Analytics:

• Clinical Trial Planning and Analytics (CTP&A) is accountable for end‑to‑end clinical trial feasibility activities, supporting protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs.
• This function provides data‑driven feasibility insights to enable informed decision‑making during early study planning and partners closely with Clinical Operations Leads, Clinical Development, cross-functional stakeholders and external vendors to ensure trials are designed and placed for successful execution.
• This function is responsible for predictive trial performance modeling to enable proactive implementation of contingency plans

Clinical Trial Operational Technologies:

• The Clinical Trial Operations Technology function is responsible for the strategic ownership, governance, and optimization of clinical trial operations systems that enable compliant, efficient, and inspection‑ready execution of clinical trials.
• This function serves as the business owner for core clinical systems (e.g., CTMS, eTMF, and related platforms), ensuring alignment with clinical operations needs, regulatory requirements, and the company’s development portfolio. The position partners closely with Clinical Operations Leads, Quality, Regulatory, Data Management, IT, and CROs/external vendors.
• Areas of focus for capability building include leveraging technology to enable cost-efficient trial budget builds and ongoing costs optimization during study execution, enabling tools for targeted clinical operations risk management and technology-enabled eTMF oversight.

Vendor Alliance Management:

• Vendor Alliance Management is responsible for the strategic and operational oversight of external clinical operations vendors and CRO partners supporting clinical trials, including coordination of vendor due diligence for vendor qualification. Ensures vendors deliver high‑quality services in compliance with GxP and contractual expectations, while enabling efficient study execution across one or more clinical programs.
• Vendor Alliance Management is the primary interface between internal Clinical Operations Program Leads and external service providers, with accountability for vendor governance, performance management via objective metrics, issue escalation, and continuous improvement.

Site contracts and Payments

• Site Contracts & Payments is responsible for creating and overseeing a scalable and effective operating model for site contracting visibility, investigator payment operations, serving as a central point of accountability for improving operational control, process effectiveness, financial discipline, vendor performance consistency, and sponsor-CRO-site workflow alignment.

Sample and Imaging Management Operations

• Sample and Imaging Management is responsible for end-to-end sample and imaging oversight across Legend pipeline studies. To strengthen visibility, accountability, and coordination across sites, CROs, central labs, specialty labs, imaging vendors.
• Sample and Imaging Management focuses on system‑level consistency and risk reduction, mitigating against loss of patient data, enabling acceleration of data cleaning and reducing site burden for participation in clinical trials.
• Lead business owner for clinical operations standards and practices, including functional owner for clinical operational related SOPs and guidance documents.
• Performs other duties as required.

Key Relationships

• The Head of Clinical Operations Capabilities and Standards works closely with all applicable internal cross-functional leaders and teams as well as external vendors for the clinical operations capability building and strengthening.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• 12+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership responsibility across global clinical development programs.
• Significant experience in establishing, scaling, or transforming centralized Clinical Operations capabilities, including one or more of the following:
  • Clinical Trial Planning & Analytics / Feasibility
  • Clinical Trial Operational Technologies (e.g., CTMS, eTMF, analytics platforms)
  • Vendor Alliance Management
  • Site Contracts and Investigator Payments
  • Sample and Imaging Management Operations
• Proven expertise in end‑to‑end clinical trial conduct, including early‑phase through late‑phase trials, with strong understanding of protocol development, feasibility, start‑up, execution, and close‑out.
• Demonstrated strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.
• Experience acting as a functional or enterprise‑level clinical operations subject‑matter expert, defining standards, operating models, and best practices applied across multiple studies or programs.
• Strong background collaborating with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions in a matrixed global environment.
• Experience participating in and/or supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct is strongly preferred.
• Demonstrated success leading, developing, and retaining high‑performing teams, including functional leaders.
• Willingness to travel as required (approximately 10%).
• Deep knowledge of clinical trial operations frameworks, including industry best practices and regulatory expectations (ICH‑GCP, FDA, and global health authorities).
• Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability.
• Demonstrated leadership in clinical operations technology enablement, including business ownership of systems (e.g., CTMS, eTMF), data quality oversight, technology‑enabled risk management, and inspection readiness.
• Expertise in vendor and alliance management, including development of governance structures, KPI frameworks, financial oversight, and performance optimization.
• Understanding of clinical trial sample, imaging, and data flows, with ability to design operational controls that reduce patient data risk, site burden, and cycle times.
• Ability to translate portfolio‑level strategy into executable clinical operations capabilities, standards, and guidance.
• Proven strategic and critical thinking skills, with a data‑driven mindset and ability to anticipate operational risks and mitigation strategies.
• Strong experience developing, authoring, and governing clinical operations SOPs, standards, and guidance documents.
• Exceptional communication, presentation, and stakeholder influence skills, with the ability to engage senior leadership and cross‑functional teams.
• High proficiency with clinical operations–relevant technologies and tools, including MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for operational decision‑making.

#Li-AS1

#Li-Hybrid

Legend Biotech is seeking a Program Lead, Cell and Gene Therapy as part of the Global Manufacturing and Supply team based in Raritan, NJ.

Role Overview

The program Lead will be responsible for developing and executing the internal commercial manufacturing strategy for iLVV (in vivo Lentiviral Vector). This role will lead strategic planning, drive execution, propose options to senior leadership, of the commercial manufacturing introduction activities across late-stage and commercial programs, ensuring technical excellence, regulatory readiness, operational execution, and seamless cross-functional alignment. The position requires close collaboration with cross-functional teams including R&D, process development, MSAT, global facility & engineering, Quality, procurement, regulatory affairs, and finance.

Key Responsibilities

Strategic Leadership

• Define and drive the internal commercial manufacturing strategy for iLVV.
• Evaluate internal/external options for iLVV commercial manufacturing, and seek stakeholder feedback.
• Present options and recommendations to senior leadership for decision-making.
• Provide clear, concise, and timely updates to senior management regarding program progress, risks, and strategic considerations.
• Motivate and inspire cross-functional teams, building momentum, alignment, and ownership.
• Make decisive, data-driven, and sometimes tough decisions to advance program objectives under aggressive timelines.

Planning & Execution:

• Develop detailed business and implementation plans and timeline for late stage clinical and commercial manufacturing to deliver launch milestones.
• Oversee facility fitness and readiness and ensure alignment with stakeholders on commercial tech transfer and production timelines.

Cross-Functional Collaboration

• Partner with R&D for process development and technology transfer.
• Work closely with engineering and Somerset facility teams for infrastructure planning.
• Drive decision-making that balances scientific rigor, speed, risk, and business impact.
• Coordinate with regulatory and quality teams to ensure compliance with global standards.
• Collaborate with finance to manage budgets and cost projections.

Process Development & Transfer

• Working with MSAT to drive commercial process transfer activities from development to manufacturing.
• Coordinate generation of process descriptions, control strategies, equipment requirements and Bill of Materials.
• Drive establishment of raw material requirements, QC method readiness and facility fit.
• Ensure robust scale-up and validation of vector manufacturing processes.

Manufacturing Site & Operational Readiness

• Ensure manufacturing facilities are prepared for the new product including capacity, equipment, utilities, and staffing.
• Partner with Supply Chain to secure long-lead materials, single-use components, and critical suppliers.
• Oversee line-of-business readiness: QA, QC, MSAT, warehouse, digital systems, labeling, analytics.
• Align on operational procedures (SOP updates, batch records, deviations/corrective actions).

Quality and Compliance

• Ensure compliance with applicable global GMP, ICH, and regulatory expectations.
• Support CMC submissions, PPQ documentation, change controls, and validation packages.
• Collaborate with Quality to ensure inspection readiness and audit support.

Continuous Improvement & Lifecycle Management

• Identify opportunities to optimize manufacturing robustness, cost, and yield post-launch.
• Implement lessons learned, knowledge management systems, and NPI best practices.
• Support product lifecycle changes such as process improvements, site expansions, and supply chain enhancements.

Requirements

Education

BS is required, Ph.D. preferred in Biotechnology, Biochemical Engineering, or related field.

Experience

• Minimum 10+ years in biopharmaceutical manufacturing. Viral vector late processes development/manufacturing experience is required.
• Proven experience in facility scale and layout planning, and commercial process transfer and validation.
• Strong understanding of cGMP requirements and regulatory frameworks for cell and gene therapy products.

Skills

• Strategic thinking and ability to build consensus among peers and influence senior leadership.
• Excellent project management and cross-functional leadership skills.
• Strong communication and stakeholder management capabilities.
• Ability to thrive in a fast-paced, evolving environment.
• Highly goal-oriented, ownership-driven, and laser-focused on execution.
• Comfortable navigating ambiguity and making quick, high-impact decisions.

#Li-BZ1

#Li-Hybrid

Legend Biotech is seeking a Manager, Competitive Intelligence as part of the Commercial team based in Somerset, NJ.

Role Overview

The of Competitive Intelligence (CI) will serve as a strategic thought partner responsible for generating actionable insights that inform decision-making across R&D, commercial, and corporate strategy functions. This individual will lead proactive and on-demand CI initiatives, including competitor monitoring, landscape assessments, early signal detection, conference surveillance, and strategic analysis that supports pipeline development, lifecycle management, and long-term planning. The ideal candidate is a highly analytical, collaborative, and business-oriented professional with strong communication skills and a deep understanding of the biopharmaceutical landscape.

Key Responsibilities

Strategic Intelligence & Insight Generation

• Lead competitive intelligence activities across assigned therapeutic areas, platforms, and/or programs, delivering high-quality, actionable insights to senior leadership and cross-functional stakeholders.
• Conduct comprehensive landscape assessments, including scientific, clinical, regulatory, and commercial dimensions.
• Monitor competitors’ pipelines, clinical data, regulatory actions, collaborations, and market events to identify emerging threats, opportunities, and early signals.
• Monitor new entrants and startup tracking: Monitoring early innovation signals, investments, and disruptive players
• Synthesize complex data into clear narrative insights and strategic recommendations.

Conference Coverage & Surveillance

• Lead end-to-end conference CI planning and execution, including surveillance plans, abstract triage, onsite (or virtual) monitoring, rapid-readouts, and post-conference summaries.
• Coordinate cross-functional stakeholders to ensure aligned priorities and actionable outputs.

Data & Analysis Leadership

• Build and maintain CI frameworks, dashboards, market landscapes, and tracking systems to support continuous monitoring.
• Manage internally created CI dashboard and in some cases external CI vendors and ensure high-quality deliverables aligned with business needs.
• Develop and implement CI best practices, tools, and standardized processes.

Cross-Functional Partnership

• Serve as CI lead for R&D, commercial, BD, and strategy teams; participate in team meetings and strategic discussions as an insights partner.
• Partner with forecasting, medical affairs, and commercial strategy to ensure cohesive interpretation of external environment dynamics.
• Required to make decisions on a day-to-day operations for their tasks, and technicalities related to CI mostly. 

Requirements

• Master’s in life sciences, business, or related field
• 3+ years of experience in pharmaceutical/biotech competitive intelligence, strategy, consulting, market research.
• Strong scientific and clinical acumen in relevant therapeutic areas; hematology/oncology and Autoimmune experience preferred (if applicable).
• Demonstrated track record of delivering strategic insights and influencing decision-making.
• Strong analytical and strategic thinking abilities.
• Excellent written and verbal communication skills; ability to distill complex information into clear insights.
• Highly proficient in CI methodologies, secondary research, data interpretation, and triangulation.
• Skilled at working in fast-paced, cross-functional environments with tight timelines.
• High integrity and ability to manage sensitive/confidential information.
• Familiarity with CI tools, databases, and information platforms (e.g., Evaluate, Cortellis, Datamonitor, Alphasense, and clinical databases). 

#Li-

#Li-

Legend Biotech is seeking a Sr. Medical Science Liaison as part of the Medical Affairs team based Remotely in the Mid Atlantic Territory.

Role Overview

The Senior Medical Science Liaison (MSL) is a field‑based scientific expert within U.S. Medical Affairs, responsible for fostering credible, compliant, and non‑promotional scientific exchange with healthcare professionals (HCPs), investigators, and other external stakeholders in hematology/oncology.

This role serves as a key scientific partner across academic and community settings, supporting Legend Biotech’s marketed and pipeline assets through evidence‑based dialogue, clinical trial support, medical education, and generation of actionable medical insights. The Senior MSL operates with a high degree of autonomy, contributes to territory and national medical strategy execution, and may mentor or support the development of junior MSL colleagues.

Key Responsibilities

Scientific Engagement & External Partnerships

• Develop and maintain long‑term, peer‑to‑peer scientific relationships with key opinion leaders (KOLs), investigators, and other relevant healthcare stakeholders within the assigned territory.
• Deliver fair‑balanced, scientifically rigorous medical information in response to unsolicited requests, consistent with PhRMA Code, FDA regulations, and company SOPs.
• Serve as a trusted scientific resource on disease state, mechanism of action, clinical data, and emerging evidence related to Legend Biotech and relevant competitive landscapes.

Clinical Research & Development Support

• Act as the primary field‑based medical contact for investigators and research staff involved in company‑sponsored and investigator‑initiated studies.
• Support clinical trial feasibility, site identification, site initiation, and enrollment discussions in collaboration with Clinical Development and Clinical Operations.
• Provide education and support related to protocol concepts, safety reporting, and adverse event (AE) management, as appropriate and compliant.

Medical Strategy Execution & Insights

• Execute Medical Affairs strategies and tactics at the territory level in alignment with national medical plans.
• Collect, synthesize, and communicate high‑quality medical insights related to clinical practice, unmet needs, treatment paradigms, and competitive intelligence.
• Translate field insights into actionable recommendations for internal stakeholders to inform medical, clinical, and research strategies.

Scientific Exchange & Medical Education

• Support and participate in scientific congresses, symposia, advisory boards, and investigator meetings.
• Interpret scientific data presented at meetings and communicate key findings, trends, and implications to cross‑functional partners.
• Contribute to the development and continuous improvement of medical resources, training materials, and scientific content.

Cross‑Functional Collaboration & Leadership

• Collaborate effectively with internal partners including Medical Affairs, Clinical Development, Commercial (as appropriate), Regulatory, and strategic alliance teams while maintaining appropriate medical independence.
• Collaborate with alliance partners on field-based strategies and tactics
• Mentor and provide informal leadership support to newly hired or less experienced MSLs, as needed.
• Demonstrate strong judgment, adaptability, and professionalism in complex and evolving environments.

Compliance & Operational Excellence

• Adhere to all company policies, SOPs, and external regulations, including PhRMA Code, FDA guidance, and internal compliance standards.
• Maintain accurate and timely documentation of field activities, insights, and metrics using approved systems and tools.
• Manage territory operations effectively, including planning, prioritization, and travel logistics.

Requirements

• Advanced terminal degree (PharmD, PhD, MD, DO) or other advanced clinical degree (e.g., NP, PA) with relevant clinical experience.
• Minimum of 3-5 years of Medical Science Liaison experience in a therapeutic area aligned with hematology/oncology, immunology or CAR-T therapy; or 3-5 years of hematology/oncology clinical experience.
• Strong foundational knowledge of clinical research, trial design, and drug development processes.
• Demonstrated ability to engage in high‑level scientific exchange with expert clinicians and researchers.
• Excellent verbal, written, and presentation skills, with the ability to communicate complex scientific concepts clearly.
• Proven ability to work independently while collaborating effectively in a matrix organization.
• Valid U.S. driver’s license and ability to travel extensively, including overnight and occasional weekend travel.
• Residence within the assigned territory or within reasonable commuting distance.
• Core Competencies:
  • Scientific and Clinical Acumen
  • Strategic Thinking and Problem Solving
  • Insight Generation and Communication
  • Stakeholder Relationship Management
  • Emotional Intelligence and Professional Presence
  • Adaptability and Change Management
  • Compliance Mindset and Ethical Judgment
  • Digital and Technical Proficiency

#Li-JK1

#Li-Remote

Legend Biotech is seeking an Associate Director, Operations Program Lead as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Operations Program Lead (OPL), Clinical Operations is accountable for accelerated operational delivery of 1-2 priority cell therapy development programs across all phases. This position is responsible for leading, managing and providing operational oversight for quality delivery within budget across all Legend Pipeline studies for 1-2 assets.

This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. This position requires a high-performing contributor with strong leadership and stakeholder management skills. This individual will collaborate with the cross functional team to develop operationally feasible program timelines and identify clinical trial operational risks and develop mitigation strategies to ensure accelerated and cost-efficient quality clinical trial execution.  In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, and represent the clinical trial operation function at internal and external meetings.

This position will oversee 1-2 contractor Clinical Trial Associates (CTA).

Key Responsibilities

Direct end-to-end clinical trial management: 

• Direct end-to-end clinical trial operations activities domestically and globally: i.e. lead and take ownership in all aspects of Study Operations for CAR-T Studies in a matrix environment.
• Responsible for the overall success of the clinical study programs
• Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. Ensures audit-ready condition of clinical trial documentation including central clinical files.
• Report on all aspects of the study progress at a granular level to stakeholders and senior leaders. Effective, consistent & regular tracking of project (s). Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Senior and Mid-level management Study Management Meetings).
• Supports the Development of strategic plans for clinical trial operations, ensuring alignment with the company's overall goals and objectives.
• Collaborate with the cross-functional "core" teams to integrate clinical operations strategies into broader development plans.
• Define project timelines & deliverables, by working closely with the cross-functional core program team for end-to-end execution of clinical trials.
• Collaborates in the preparation and/or review of study-related documents (e.g., study protocols, informed consents and amendments, Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals).

Clinical Trial Operations Efficiency and optimization:

• The OPL will drive clinical Operations excellence by playing a critical role in Clinical Trial Operations Efficiency and optimization.
• Work with cross-functional teams and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support optimal and efficient clinical trial execution. 
• The position involves working closely with the clinical development team and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, tech ops, manufacture, supply chain, regulatory, project management, medical affairs, finance, legal and quality.
• Create and Manage study trial execution RACI to support overall trial execution and operational excellence.
• Contribute to Clinical Operations functional initiatives and institution of best practices.

Resource Management and Direct High Performing team:

• Manage and build a high-performing clinical operations support structure. Duties include hiring, onboarding, training, and development of staff to manage studies.
• Lead, develop and manage study operation manual, new work-streams, SOPs, study template, tracking tools, dashboards to support optimal clinical operation performance.
• Provides study-specific training and leadership to clinical research staff, including CRO, sites and other study personnel to support clinical trial execution and optimization.

Direct and Support Vendor Partnership

• Oversee vendor selection process, management, of Contract Research Organizations (CROs) and vendors involved in clinical trial Operation (CRO, Central Lab, etc).
• Participates in CRO and vendor study related calls and meetings, holds team members accountable for actions, escalates issues and oversees all aspects of daily study operations. Ability to identify issues and risks. Develops and manages mitigations and/or escalate risks appropriately.
• Negotiates vendor contracts / budgets and presents to the executive study team for approval.
• Review and confirm CRO and site payment invoices.
• Lead vendor performance assessment for continuous process improvement
• Management/oversight of external vendor deliverables reports and budgets.
• Collaborate within Clinical Operations and with study leadership team to create preferred vendor list for clinical development.

Leadership Skills

• Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream, and lateral implications of decisions that affect study outcomes and timelines.
• Adaptable / flexible, self-starter (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Excellent team player: willingness and ability to fill functional gaps in a small organization.
• Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities.

Key Relationships

• The Operations Program Lead in Clinical Operations works closely with the asset Core Team and cross-functional teams such as safety, study monitoring, data management, biostatistics, bioanalytics, manufacturing, supply chain, regulatory, project management, medical affairs, and quality.
• Mentoring and management of a CTA.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• Oncology and/or Immunology clinical trial operations therapeutic experience required. 10+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience.
• Experience leading the operational planning and oversight of clinical trials as the point of accountability for operational delivery. (CAR-T trials experience is a plus).
• Demonstrated ability to deliver ambitious trial acceleration timelines within a competitive clinical trial landscape.
• Phase 1 clinical trial operational experience is preferred.
• Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements are essential.
• This position requires experience and leading study/project management to create study project plans, and end-to end-study timelines for execution of clinical trials.
• Demonstrated ability to multi-task and manage high performance demands.
• Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• CRO/Vendor oversight experience required.
• Project Management (biotech) experience a plus.
• Regulatory authority inspection experience a plus.
• Ability to travel as necessary (approximately 10 – 15 %); both domestically and internationally.
• Effective oral, written and interpersonal communication skills.
• Strong communication and presentation skills.
• Forward and critical thinker.
• SOP development experience preferred.
• Strong organizational and project management skills, and the ability to multitask.
• Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
• Excellent working knowledge GCP, FDA and ICH Guidelines.

#Li-AS1

#Li-Hybrid

Legend Biotech is seeking a Head, Business Operations and Alliance Management as part of the Commercial team based in Bridgewater, NJ.

Role Overview

Reporting directly to the President, Carvykti BU, this role serves as the BU’s Strategy & Execution Lead, driving alignment, execution, and operational effectiveness across Commercial, GMS, Quality, and Medical Affairs. A core responsibility is managing Legend’s strategic alliances—ensuring strong governance, seamless communication, and proactive issue resolution so both organizations deliver on joint CAR‑T objectives.

The role also leads BU‑wide engagement and communication, fostering clarity, connection, and cultural cohesion across global teams. In parallel, it drives capability building, strengthening organizational readiness, talent development, and cross‑functional effectiveness to support Carvykti’s rapid growth and strategic priorities.

Key Responsibilities

Alliance Management:

• Lead governance of current and future alliances, ensuring transparent communication, shared accountability, and timely escalation.
• Coordinate joint steering committees, joint working teams, and governance bodies to ensure compliance with collaboration agreements and delivery on shared milestones.
• Maintain a strong relationship with partner organizations (e.g., Janssen) and serve as a central connective point between Carvykti BU functional stakeholders and alliance partners.
• Proactively identify risks, misalignments, or emerging strategic opportunities within collaborations and drive resolution or acceleration initiatives.
• Ensure open communication channels across both organizations and consistent partnership health tracking.

Engagement & Communication:

• Drive engagement initiatives and forums - town halls, BU business reviews, culture initiatives, leader communications, and cross‑functional alignment sessions.
• Serve as a strategic advisor to the BU President on messaging, engagement cadence, and organizational pulse.
• Design and lead BU‑level internal communications strategy, ensuring clarity, transparency, and alignment from the President through LT‑1 and field/operational teams.

Innovation & Strategy Acceleration:

• Partner with BU President & LT to shape and drive BU strategic initiatives, including transformation, digital capability scaling, operational innovation, and cross‑functional initiatives.
• Monitor industry trends (CAR‑T evolution, regulatory updates, partnership models) and translate insights into BU priorities.

Capability Building:

• Support BU‑wide capability strategy (technical, leadership, and operational), to ensure teams are equipped for current and future needs across Commercial, GMS, Quality, and Medical Affairs.
• Build mechanisms to measure capability maturity and organizational effectiveness.
• Partner with HRBP, OD, and Functional Heads to design learning ecosystems and talent acceleration pathways.
• The Head, Business Operations and Alliance Mgmt. exercises independent decision-making authority across strategic and operational domains, including project scope, timelines, resource allocation, and vendor selection. Decisions related to significant budget changes, strategic shifts, or major collaborations require higher-level approvals. This role is expected to proactively identify issues, propose solutions, and guide cross-functional execution with minimal oversight.

Requirements

• Advanced degree (MBA, MS) preferred; background in cell therapy, biotech, strategy, or operations strongly desirable.
• 10+ years’ in Pharma / Biotech with experience in alliance management, strategy execution, business operations and cross-functional leadership.
• Demonstrated success managing high‑complexity external partnerships and governance structures.
• Experience working with or leading within matrix organizations across Commercial, GMS, Quality, and Medical Affairs is highly desirable.
• Proven track record in driving organizational capability building, communication strategies, or enterprise‑level initiatives.
• Strong written and verbal communication skills; executive‑level presence.
• Strategic systems thinker with ability to distill complexity and drive clarity.
• Exceptional stakeholder management and influence.
• Strong program management, change management, and problem‑solving capability.
• High agility, ability to manage ambiguity, and proactive issue resolution.
• Culturally intelligent and globally collaborative.

#Li-JK1

#Li-Hybrid

PrizePicks is seeking a strategic and execution-oriented Chief Communications Officer to lead our internal and external communications strategy. Reporting directly to the CEO, the CCO will shape how PrizePicks is understood by employees, players, regulators, media, partners, and the broader public. This leader will ensure the world knows that PrizePicks is a fast-growing, innovative, responsible, and consumer-first entertainment company.

What you’ll own:

• Corporate Narrative & Brand Positioning: Develop and refine the corporate story and ensure consistent messaging across all channels. 
• Media & Public Relations: Build a world-class PR function and elevate executive visibility.
• Internal Communications & Culture: Align employees around company priorities and support change management. 
• Crisis & Reputation Management: Lead crisis communications planning and response.
• Government & Regulatory Messaging: Partner with Legal/Public Affairs to ensure consistent compliance messaging. 

What success looks like:

• PrizePicks is recognized as a premier consumer entertainment brand.
• Share of voice and media sentiment improve year-over-year.
• Strong internal alignment on strategy and performance.

What you bring:

• 15+ years of progressive communications leadership experience.
• Experience scaling communications at a high-growth consumer, tech, gaming, or entertainment company. 
• Strong understanding of regulated industries preferred.
• Proven crisis management experience.
• Exceptional executive presence and board-level influence.

Where you’ll live:

• This is a hybrid position based at our PrizePicks headquarters in Atlanta, GA. #LI-Hybrid

Job Summary: The Government Affairs Associate will support the Chief of Staff and Head of Government Affairs in managing domestic and international external relations with government entities, tracking policy developments, and coordinating advocacy efforts. This role focuses on maintaining trade associations, regulatory monitoring across global jurisdictions, reporting dashboards, and interfacing with key stakeholders to advance the organization's interests in legislative and regulatory matters worldwide.

Location: Hybrid in the Center Valley, PA area 

Key Responsibilities:

• Manage trade association memberships and participation, including renewals, event coordination, and representation on behalf of the organization at both domestic and international levels.
• Track regulatory and legislative developments at federal, state, local, and international levels, providing timely summaries and impact assessments to leadership.
• Coordinate lobbyist activities and deliverables, ensuring alignment with organizational goals and monitoring progress on domestic and international advocacy initiatives.
• Interface with legal and compliance teams to align government affairs strategies with internal policies and risk management, including global regulatory compliance.
• Support congressional, agency, and international engagements (e.g., with foreign governments or multilateral organizations), including preparing briefing materials, scheduling meetings, and following up on action items.
• Collaborate with cross-functional teams to gather inputs on policy positions, report global policy risks to executive leadership, and contribute to enterprise-wide risk monitoring.
• Assist in ad-hoc tasks such as policy research, stakeholder mapping, or supporting global policy strategies, as needed.

Qualifications:

• Bachelor's degree in Political Science, Public Policy, International Relations, or a related field.
• 3–5 years of experience in government affairs, public policy, advocacy, or related roles, preferably in a corporate or association setting with international exposure.
• Strong knowledge of domestic and international regulatory and legislative processes, with experience tracking global developments and building relationships with stakeholders.
• Excellent research, analytical, and organizational skills with attention to detail.
• Superior communication abilities for interfacing with internal teams, lobbyists, and external officials across cultures and time zones.
• Preferred: Experience in trade associations, lobbying coordination, international policy, or certifications in public policy (e.g., relevant professional associations).

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

 #LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

The Opportunity:

• Manage planning, preparation (including authoring when appropriate), coordination, and submission of regulatory documents to global National Health Authorities that meet ICH and FDA standards, and other local or regional regulatory requirements.

• Such submissions may include Clinical and Preclinical content. 

• Assist and keep detailed timelines for regulatory activities and submissions. 

• Perform regulatory research to assess regulatory implications and inform business strategy for drug development and approval.

• Assess and communicate risks. 

• Ensure that there are no significant interruptions to the business due to regulatory compliance issues. 

• Correspond and collaborate across the organization at all levels, across functional groups, and with executive management. 

• Support NDA filing activities and assist with developing regulatory process supporting the filing. 

• Prepare and manage routine submissions and related activities. 

• Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations. 

• Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.

Required Skills, Experience and Education:

• Bachelor’s degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields.  

• Three (3) years of experience in Regulatory Affairs department at a drug or biologics company.  

• Employer will accept a Master's degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields and one (1) year of experience in Regulatory Affairs department at a drug or biologics company.

• Work experience to include:

• Manage the preparation and submission of initial IND (Investigational New Drug) application and subsequent amendments;

• Manage the development of regulatory submissions in eCTD (electronic Common Technical Document) format;

• Interpret and apply FDA (Food and Drug Administration), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), EMA (European Medicines Agency), or PMDA (Pharmaceuticals and Medical Devices Agency) regulations to oncology drug development;

• Manage global regulatory health authority filings and subsequent amendments.

• Successful completion of background checks and employment history verification required.  

• 100% remote position reporting to Revolution Medicines, Inc. in Redwood City, CA.  Candidate may live anywhere in the continental U.S.

The Opportunity:

The Vice President, Regulatory Affairs will manage several key U.S. based regulatory functions and report to the SVP of Regulatory and Quality. The position is responsible for expanding and leading a large, high functioning regulatory group and ensuring global alignment.

• Provide ethical and mission-driven leadership of the Regulatory Affairs functions. Embody and practice the company’s mission-driven culture. Ensure that our core values guide our strategic vision and our day-to-day decision making.

• Provide a vision for the Regulatory Affairs organization and develop a plan to achieve it. Design and rapidly scale a group to meets the needs of an explosive pipeline in areas of high unmet medical need and intense industry competition.

• Influence decision-making of senior leadership and ensure globally aligned regulatory decision-making.

• Collaborate closely and form effective relationships with other functional heads and regional counterparts to ensure high quality, cross-functionally sound decision-making.

• Collaborate with peer leaders and management to ensure regulatory considerations are integrated upstream appropriately, e.g., target product profiles, clinical development plans, financial planning.

• Ensure consistency in approach (one playbook) and that learning occurs across staff and disciplines.

• Continue to build the Regulatory Affairs group, strategizing with other leaders to maximize enterprise-wide impact locally and globally.

• Actively lead the function and support team member career development.

Required Skills, Experience and Education: 

• Local to San Francisco Bay Area or able to travel to headquarters frequently and for adequate durations (up to 25%).

• BA/BS degree in life sciences or related disciplines.

• At least 15 years of experience in drug development regulatory affairs.

• Minimum of 10 years of experience in regulatory leadership or executive role.

• Significant oncology experience.

• Expertise in navigating global regulatory environments in a commercial setting.

• Ability to successfully work in a fast-paced, demanding and highly cross-functional environment.

• Experience scaling an organization rapidly.

• Clearly understands the role of regulatory science in drug development and global commercialization, and is comfortable with ambiguity, risk, and optimizing for business needs.

Preferred Skills:

• Advanced degree in life sciences enabling technical fluency in oncology.

• Prior senior regulatory executive in oncology drug development at a medium or large pharmaceutical enterprise but who also understands the startup environment.

#LI-Hybrid  #LI-GL1 

Position Description

The Director, Regulatory Labeling, Advertising & Promotion (LAP) is responsible for leading global product labeling and U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure labeling and promotional materials are scientifically accurate, compliant with regulatory requirements, and aligned with corporate and commercial objectives.

The position serves as a key regulatory partner to Clinical Development, Medical Affairs, Commercial, Legal, and Safety, and plays a central role in labeling strategy, lifecycle management, and promotional material review in a highly regulated environment, for cell and gene therapy products.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Job Duties and Responsibilities

Core Responsibilities:

Labeling

• Lead the development, negotiation and lifecycle maintenance of global and US product labeling, including pre- and post- approval updates.
• Drive development and maintenance of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI), ensuring alignment with global regulatory expectations.
• Establish and operationalize labeling strategies that result in clear, concise, compliant and scientifically robust product labels.
• Provide regulatory leadership for labeling-related interactions with Health Authorities, including briefing documents and responses to inquiries.
• Ensure final labeling content meets internal standards and regulatory authority requirements prior to submission or implementation.

Advertising and Promotion

• Oversee regulatory review of US promotional and select non-promotional materials. across channels, ensuring compliance with FDA regulations and enforcement trends
• Serve as the regulatory lead and reviewer for Medical-Legal-Regulatory (MLR) review.
• Partner with Commercial, Medical Affairs and Legal to proactively identify and mitigate regulatory risk in promotional strategy and execution.
• Monitor and interpret FDA enforcement actions and policy developments related to advertising and promotion, translating insights into internal guidance and best practices.
• Develop submission strategy for efficient and appropriate health authority review of promotional materials; and ensure the compliant and timely submission of promotional materials to Health Authorities.
• Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions.

Governance, Process and Compliance

• Support or co‑lead the Labeling Review Committee (LRC) and provide regulatory oversight of labeling governance processes.
• Develop, maintain, and improve SOPs, workflows, tools, and training related to labeling and Ad/Prom review.
• Ensure inspection readiness and documentation compliance for labeling and promotional activities.
• Drive consistency and operational excellence across labeling and Ad/Prom processes globally.

Cross-Functional Leadership

• Act as a strategic regulatory advisor to Clinical, Safety, Medical Affairs, Commercial, Quality, and Regulatory Strategy teams.
• Lead and mentor internal staff and manage external vendors or consultants as needed.
• Contribute to broader regulatory strategy discussions.

Essential/Required Qualifications:

• Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies.
• Experience supporting FDA interactions related to labeling and promotional compliance
• Experience with MLR review and developing Company Core Data Sheets
• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Proven ability to lead cross-functional teams and to operate in a matrixed organization, including leadership without direct authority.
• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree)
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Ability to influence without authority and partner effectively with senior leaders.
• Strong attention to detail and accuracy with sound judgement and risk-based decision making.
• Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines, motivates others, demonstrates tact and diplomacy, and has a flexible and positive solution-oriented approach.

Key Competencies:

• Deep understanding of FDA regulations and guidance governing labeling and promotional materials.
• An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.

The Opportunity:

We are seeking an experienced drug developer and effective leader to serve as Executive Director of Clinical Development in support of Revolution Medicines’ clinical-stage molecule(s) and/or pre-clinical molecule(s). In this critical role, you will be responsible for developing the strategic plans and ensuring efficient operational execution of the molecule(s)’ clinical development program in one or more disease indications, from early-stage studies to regulatory submissions and potential commercialization. You will play a pivotal role in shaping the future of our pipeline and driving the development of transformative therapies for patients.

• Provide critical insights/contributions and implement comprehensive/execute upon the clinical development plans for Revolution Medicines’ molecules, ensuring alignment with scientific, regulatory, and commercial objectives.

• Lead, mentor, and manage a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.

• Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.

• Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.

• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.

• Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development.

• Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals.

• Manage multiple direct reports; potentially be a manager of managers.

Required Skills, Experience and Education:

• MD, PhD or similar advanced biomedical graduate degree with 13+ or more years experience in pharmaceutical/biotech industry or academic background at the level of Associate Professor or higher.

• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.

• Proven track record of successfully designing and conducting multiple clinical trials as part of a wider clinical development programs from early-stage to late-stage, direct experience with Phase 1 drug development.

• Experience authoring and clinical development strategy(ies) and bringing forward for governance.

• Extensive understanding of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations.

• Proven experience to steer an IMP during its clinical development plan through major and varied Health Authority interactions (e.g. FDA, EMA, others). Has led Health Authority interaction(s).

• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills, with the ability to inspire, motivate and mentor a diverse team.

• Expertise in building and maintaining strong relationships with internal and external stakeholders.

• Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals.

• Outstanding written and business presentation skills. Experience publishing results of a clinical trial in a peer-reviewed journal is required.

• Proven ability to manage budgets and timelines effectively.

• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.

Preferred skills:

• Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.

• Experience creating clinical development strategy(ies) that led to label-enabling outcomes and commercialization.

• Experience submitting an NDA/BLA/MAA to global health authorities is a significant plus.

• Has led regulatory and other internal partners/stakeholders in the completion and submission of regulatory documentation. Successfully provided clinical science information and input for regulatory development of label(s) and packaging language, etc.

• Has led or overseen data generation to address unmet medical needs and identify new or extended Clinical Development studies for the assigned program or other programs.

• Direct experience with Phase IV drug development.

• Has proven abilities to present [a] compelling business case and facilitates effective and expeditious decision-making. Has demonstrated the ability to serve as a company spokesperson both internally and externally.

• Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes (e.g. new study proposals or new disease indications).

• Has demonstrated courage and conviction in past positions and responsibilities. Skilled in conflict resolution.  

  #LI-Hybrid  #LI-GL1

About the Opportunity

Our commercial team is growing and looking for a Clinical Account Manager based in Nashville/Raleigh
to help support our growth. You will play a critical role in supporting Cleerly’s growth and
success of current clients/partners by making sure they understand our product offerings and
helping patients get Cleerly scans. Reporting to the Regional Director of Sales, this role will be
working with clinical partners to find expansion opportunities as well as to provide ongoing
clinical education to grow existing Cleerly accounts.

You will be responsible for identifying growth opportunities, maintaining relationships with
existing high-value partners, and representing Cleerly as a leader in the industry to positively
impact the lives of millions. The ideal candidate is highly motivated, has a clinical background, is
client focused, result-oriented, and mission-driven. You will work with clinics to ensure that they
are extremely successful with Cleerly’s cardiovascular diagnostic technology by proactively
supporting, educating, and providing high customer satisfaction. This is a customer- facing role
with a primary focus on spending time with customers including Cardiologists. This is a
field-based role, but you must be based in or near Nashville/Raleigh, as it will be a key market in
your assigned territory. 

Responsibilities

• Manage and maintain relationships with clinical partners to make sure they understand
  Cleerly and how Cleerly helps Providers in their treatment decisions for patients.

• Account development - Experience building and supporting strong clinical programs is
  preferred.

• Clinical / technical proficiency - Quick learner able to grasp new clinical/technical
  information and then disseminate to customers.

• Develop relationships with key account stakeholders, to include admin, admin support,
  key cardiologists, key referring physician practices, and key strategic personnel to drive
  awareness of Cleerly’s offerings and promote adoption.

• Customer-focused mentality.

• Drive new product and technology introductions for existing customers.

• Develop a qualified lead funnel within the existing base. Regular activities consist of
  formal presentations, peer-to-peer education, new physician training, and driving
  physician education.

• Use Salesforce.com to manage administrative tasks.

• Travel to various provider sites within a territory 50-80% of the time including the following states: NC, TN

Requirements

• Degree from accredited college/university.
• 5+ years of related sales or clinical experience (PA, NP, DNP or RN).
• Prior experience in medical device, cardiology pharmaceuticals, cardiology
  radio-pharmaceuticals, hospital, or medical software is highly desired.
• Highly coachable with the ability to learn and communicate complex programs and value
  propositions.
• Strong interpersonal and relationship-building skills, polished communications, the ability
  to manage multiple customer and internal company interactions.
• Effective project management skills while embracing change and driving solutions in
  otherwise chaotic environments.
• Exceptional written and verbal communication skills.
• A hard-worker, self-motivator with can-do approach and bias for action.
• Highly responsive with the ability to interpret appropriate next step actions.
• Ability to collaborate cross-functionally with both internal and external stakeholders
  across a vast geographic region.
• Experience with introducing new cardiovascular technologies into hospitals is highly
  desired.
• Ability to accurately assess and understand different stakeholders needs/wants. Process
  cross functional agendas and adjust strategy to achieve desired outcomes.
• Grit, high integrity, values-based work ethic.

The base salary range for this role is aligned to market benchmarks and determined by experience, skills, and internal equity.

This role is eligible for annual On Target Commission, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $130,000 - $140,000
• Commission: $90,000
• TTC: $220,000 - $230,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

Team Description:

The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is critical  in translating Neuralink’s BCI technology for clinical use!

Job Description and Responsibilities:

As a Clinical Program Manager, you will be the primary architect of Neuralink’s human clinical trial operations, transforming high-level strategy into rigorous, executable clinical programs. We are seeking a high-autonomy leader who thrives on ambiguity and drives projects to completion with surgical precision. In our hyper-dynamic environment, you aren't just managing timelines—you are building the infrastructure for the future of neurotechnology. You will be expected to:

Strategic Oversight & Relationship Management

• Act as the Principal Lead for complex clinical programs, owning end-to-end delivery and ensuring all milestones align with broader organizational objectives.
• Cultivate High-Stakes Partnerships across internal engineering and regulatory teams, as well as external vendors, strategic partners, and world-class clinical research sites.
• Champion Stakeholder Readiness by overseeing the training and credentialing of cross-functional teams, ensuring every contributor is equipped to operate within the trial’s rigorous requirements.

Operational Excellence & Scalability

• Engineer Scalable Frameworks to expand clinical operations across diverse global geographies, prioritizing safety, quality, and regulatory compliance at every inflection point.
• Lead Commercial & Financial Negotiations with trial sites, driving contract execution, budget optimization, and long-term financial planning to maximize trial efficiency without compromising site engagement.
• Drive Data Intelligence by leading the synthesis and analysis of clinical data to provide actionable insights for program refinement.

Compliance & Regulatory Stewardship

• Navigate Global Regulatory Landscapes to secure study approvals and maintain impeccable standing with Institutional Review Boards (IRB), Research Ethics Committees (REC), and relevant governing bodies.
• Enforce Rigorous Quality Standards, maintaining an expert-level command of Good Clinical Practices (GCP), international regulatory requirements, and site-specific Standard Operating Procedures (SOPs).
• Foster a Culture of Accountability, proactively identifying operational risks and implementing mitigation strategies to ensure the integrity of the clinical program.

Required Qualifications: 

Strategic Leadership & Clinical Expertise

• Extensive Industry Tenure: 7+ years of progressive leadership experience in clinical research, specifically within Class III medical devices, neurology, or high-complexity life sciences.
• Clinical Architecture: Advanced proficiency in clinical study design, endpoint selection, and the development of robust data analysis plans for first-in-human or pivotal trials.
• Regulatory Mastery: Deep technical knowledge of Global Good Clinical Practice (GCP) and international regulatory standards (e.g., ISO 14155, MDR, FDA 21 CFR Part 812).

Data Intelligence & Analytical Rigor

• Quantitative Fluency: Professional experience leveraging statistical methods or programming languages (Python, R) to drive data-led decision-making and trial optimization.
• Complex Problem Solving: Proven track record of interpreting multi-dimensional datasets and translating complex scientific findings into executive-level strategy.
• Meticulous Precision: A high-level of organizational rigor with the ability to manage competing high-priority workstreams in a fast-paced, high-stakes environment.

Communication & Interdisciplinary Integration

• Cross-Functional Catalyst: Demonstrated success leading integration between neural engineering, clinical neurosurgery, and regulatory affairs to achieve unified program goals.
• Scientific Diplomacy: Exceptional written and verbal communication skills, with the ability to distill complex technical and clinical concepts for diverse audiences, from internal engineers to external ethics committees.
• Operational Autonomy: A self-starting leader who initiates critical workstreams independently and maintains a relentless focus on deadline accuracy and operational efficiency.

Mission-Critical Mindset

• High-Stakes Resilience: A documented history of thriving in high-pressure, rapidly evolving environments where pivots are frequent and the margin for error is razor-thin.
• Advocacy & Influence: Strong presence and "scientific diplomacy" skills, with the ability to represent Neuralink’s clinical vision to world-class neurosurgeons, key opinion leaders (KOLs), and global health authorities

Preferred Qualifications: 

Advanced Academic & Technical Background

• Advanced Degree: PhD, MD, or Master’s degree in a relevant field (e.g., Neuroscience, Biomedical Engineering, Clinical Research, or Biological Sciences).
• Neurotech Specialization: Direct experience managing clinical trials for Class III active implantable medical devices (AIMDs), specifically Brain-Computer Interfaces (BCI) or Neuromodulation systems.
• Computational Fluency: Advanced proficiency in Python or R for automated data visualization, clinical dashboarding, or sophisticated statistical modeling.

Strategic Clinical Leadership

• First-in-Human (FIH) Mastery: Proven success in leading Early Feasibility Studies (EFS) and navigating the unique safety and ethical rigors of pioneering human trials.
• Global Expansion Experience: Experience scaling clinical operations across international jurisdictions, including familiarity with O-US regulatory bodies and localized clinical trial infrastructure.
• Financial Stewardship: Demonstrated expertise in multi-million dollar budget management, including sophisticated resource allocation and vendor contract optimization.

Innovation & Process Design

• Clinical Systems Architecture: Experience implementing and optimizing Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and eTMF platforms for high-growth environments.
• Agile Clinical Operations: Ability to apply "lean" or "agile" methodologies to clinical trial workflows, reducing cycle times while maintaining absolute compliance.
• Interdisciplinary Synthesis: A rare ability to translate high-level engineering specifications into clinical protocols that are both scientifically rigorous and operationally feasible for surgical teams.

Team Description:

Join the Quality Team at Neuralink, a group of dedicated professionals building and sustaining world-class quality and compliance frameworks from the group up. The Quality team focuses on exceeding regulatory requirements and industry best practices to enable safe and fast development of Neuralink’s innovative technologies.

Job Description and Responsibilities:

Neuralink is seeking a Document Control Specialist with strong organization skills to support document control-related activities company-wide. This role will serve as a foundational resource for organizing and managing critical documentation across the preclinical, manufacturing, engineering, quality, and regulatory departments. This position will support the maintenance, development, and scaling of processes, archiving, and compliance tracking—ensuring traceability, version control, and readiness for audits and submissions in a highly regulated environment.  Additionally, you will be expected to:

• Sustain and improve document control systems across Neuralink in alignment with FDA regulations (e.g., 21 CFR Part 11, 21 CFR 58, 21 CFR 812) and other GxP requirements
• Organize GxP files (including study records, lab data, equipment logs, and audit documentation) into a traceable, trackable, and searchable system
• Maintain archives for GxP studies and ensure proper retention, deprecation, and re-indexing as needed (including leading archive re-indexing projects to correct/improve indexing)
• Assist in SOP development, revisions, periodic reviews, and maintenance of tables of contents
• Assist with the maintenance of various study trackers, training assignments, master schedule(s), and the glossary
• Facilitate the completion of deviations and  investigations
• Manage document lifecycles: versioning, deprecation of obsolete documents, and routing/approval workflows
• Support the Regulatory department by organizing regulatory filings (e.g., new study submissions and supplements), managing uploads to the eTMF, and preparing routine submission documents (cover letters, annual reports)

Required Qualifications:

• Meticulous attention to detail and exceptional organizational skills
• Excellent verbal and written communication skills
• Strong multitasking abilities in a dynamic, fast-paced, and constantly changing environment
• Proficiency with Google Suite (Docs, Sheets, etc.) and standard document management tools
• Working knowledge of medical, scientific, and regulatory terminology

Preferred Qualifications:

• Bachelor's Degree in a relevant field, such as life sciences, engineering, technical writing/communications, regulatory affairs, or equivalent
• Relevant experience working in highly regulated environments, such as the medical device or pharmaceutical industries

Expected Compensation:

At Neuralink, your base pay is one part of your total compensation package. The anticipated hourly rate for this position is expected to be within the below range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training.

Texas Hourly Range:

$21 – $35/Hr USD

Position Overview 

We are seeking a Technical Product Manager to drive technical requirements and RAN product specifications & solutions for gateway site installation, aligning engineering needs, regulatory constraints, and deployment workflows to enable compliant, commercially viable, and scalable satellite-gateway locations. This role serves as the critical bridge between technical engineering teams, regulatory affairs, commercial development, and site deployment operations to ensure gateway delivers production-ready infrastructure that meets both technical performance requirements and business objectives. 

This position requires deep understanding of satellite ground infrastructure, RAN solutions, RF propagation considerations, regulatory compliance frameworks, and site engineering requirements. The ideal candidate will bring proven experience in technical product management within satellite communications infrastructure, with specific expertise in gateway site development, regulatory coordination, and cross-functional technical program management.  

Key Responsibilities 

Technical Requirements & Product Specifications 

• Define comprehensive technical requirements for gateway site acquisition including RF performance criteria, RAN infrastructure specifications, and integration compatibility standards 

• Manage product and deployment requirements for RAN network related hardware 

• Own configuration standards, templates, and governance to ensure consistency across Gateway sites constraints and deployment workflow requirements 

• Coordinate and validate BOMs with Engineering, Supply Chain, and vendors for completeness and accuracy 

• Establish technical validation criteria and acceptance standards for RAN network at Gateway locationa  

• Ensure CIQs, configuration guides, port mappings, and as-built documentation are complete and deployment-ready 

• Coordinate technical requirements gathering sessions with engineering stakeholders, site development teams, and operations personnel 

• Ensure technical specifications support scalable satellite-gateway location development across diverse geographical environments 

• Enable smooth technical handover to Service Acceptance and Operations, ensuring documentation completeness and traceability 

• Support change control by ensuring updates reflected across HLDs, BOMs, configurations, and documentation 

Site Feasibility & Validation Management 

• Lead technical site feasibility assessments including RF propagation analysis, interference studies, and infrastructure capability evaluations for RAN network deployment 

• Validate site feasibility against established technical criteria,  and operational deployment standards 

• Coordinate multi-disciplinary feasibility studies involving RF engineering, utilities assessment, and regulatory compliance teams 

• Manage technical risk assessments and mitigation strategies for site acquisition projects 

• Establish standardized feasibility validation processes and documentation frameworks 

Cross-Functional Engineering Coordination 

• Coordinate engineering inputs from RF engineering, satellite systems, network operations, and infrastructure development teams 

• Facilitate technical collaboration between site acquisition teams and broader satellite network engineering organization 

• Ensure consistent engineering standards and technical approaches across multiple gateway site development projects for RAN network 

• Drive technical decision-making processes involving multiple engineering disciplines and stakeholder groups 

• Enable smooth technical handover to Service Acceptance and Operations, ensuring documentation completeness and traceability 

Documentation & Delivery Standards Management 

• Manage comprehensive technical documentation for gateway site including requirements specifications, RAN Rack layout design standards, and validation procedures 

• Ensure site acquisition outputs meet integration, build, and commercial-ready gateway delivery standards 

• Establish and maintain technical documentation standards and configuration management processes 

• Maintain technical traceability from requirements through final delivery and commissioning 

Technical Program Management & Process Optimization 

• Develop and optimize technical workflows for gateway site acquisition from RAN network prospects, including requirements definition, feasibility assessment, and delivery validation processes 

• Drive continuous improvement initiatives for technical processes, tools, and methodologies 

• Coordinate technical resource allocation and capacity planning for site acquisition programs  

Qualifications 

Education 

• Bachelor's degree in Electrical Engineering, Telecommunications Engineering, Systems Engineering, or related technical field 

• Master's degree in Engineering Management, Systems Engineering, or advanced technical discipline preferred 

Experience 

• Minimum 8+ years in satellite communications, telecommunications infrastructure, or wireless network engineering 

• Minimum 5 years’ relevant experience in RAN engineering, telecom site acquisition, or technical product management supporting ground facilities 

• Demonstrated experience producing or validating site engineering deliverables: site survey reports, RF/site feasibility and integration acceptance criteria 

• Strong written communication and technical documentation skills for creating ICDs, acceptance plans and status reports 

• Ability and willingness to travel domestically to candidate and active gateway sites as required for surveys, permitting meetings, and commissioning 

Required Technical Expertise 

• Deep understanding of satellite ground segment architecture, gateway systems, and RF infrastructure requirements 

• Hands on experience of eNB hardware and RAN architecture design 

• Strong knowledge of satellite communications link budgets, antenna systems, and RF propagation characteristics 

• Proven ability to translate complex technical requirements into actionable product specifications and delivery criteria 

• Experienced on CIQ handling and deployment documentation workflows 

Preferred Qualifications 

• Background in technical product management roles at satellite operators, ground infrastructure providers, or telecommunications companies 

• Experience with technical project management methodologies and cross-functional technical program coordination 

• Familiarity with 4G/ 5G NTN standards, satellite-cellular integration, and next-generation satellite communications architectures 

Leadership & Communication Skills 

• Strong technical leadership with ability to influence and coordinate across multiple engineering disciplines 

• Exceptional communication skills for presenting complex technical requirements to diverse stakeholder audiences 

• Proven ability to manage technical programs involving regulatory agencies, engineering teams, and commercial stakeholders 

• Experience building scalable technical processes and product management frameworks 

• Demonstrated success in technical decision-making and conflict resolution across cross-functional teams 

Technology Stack 

• Proficiency with technical documentation systems, requirements management tools, and project management platforms 

• Experience with RF simulation tools, link budget analysis software, and satellite communications modelling systems 

• Knowledge of geographic information systems (GIS) and site assessment tools commonly used in telecommunications infrastructure development  

Physical Requirements 

• Role will be based in the US with flexibility for remote work arrangements 

• Regular travel for site assessments, technical meetings, and stakeholder coordination (~25-30%) 

• Ability to participate in field site evaluations including outdoor assessments at potential gateway locations 

This job description may not be inclusive to the duties and responsibilities listed. Additional tasks may be assigned to the employee from time to time or the scope of the job may change as needed by business demands. 

Your Opportunity

Scion is paving a path in student living, and we’re seeking an Insurance Claims Administrator to join our team. This position will provide essential support to corporate and property operations teams by assisting with insurance claims, legal documentation, and compliance efforts. 

This role is ideal for someone with a strong attention to detail, excellent communication skills, and an interest in legal and insurance administration.  

Your Responsibilities

• Coordinates all aspects of the making and collection of insurance claims on behalf of the Company and its managed properties.
• Responds promptly and professionally to requests for assistance from property staff.
• Drafts, revises, interprets and explains commercial contracts.
• Drafts and revises housing agreements and other relevant real estate documents.
• Identifies and responds promptly and professionally to resident complaints, vendor disputes and regulatory matters, and elevates to attorneys as required.
• Supports property operations staff with clear and consistent information regarding legal- and policy-related situations involving residents, staff and vendors.
• Supports outside counsel on litigation matters.
• Coordinates with inside and outside counsel on entity and asset acquisitions.
• Identifies and addresses various reporting and compliance issues with lenders, partners and governmental bodies.
• Monitors compliance with vendor insurance requirements.
• Monitors and assists in resolution of insurance claims.
• Other duties as assigned by Staff Attorneys, by the Vice President of Legal Affairs and/or the General Counsel.

The responsibilities listed above may not be all inclusive.

What We Require

• Associate’s degree or Paralegal certification preferred.
• 1+ years of experience in a legal, insurance, or administrative role is a plus.
• Strong organizational and communication skills.
• Ability to manage multiple tasks in a fast-paced environment.
• Proficiency in Microsoft Office and familiarity with property management systems is a plus. 

Operational Details

• Job location is based at Scion’s Chicago corporate headquarters.
• Working hours consist of standard daytime business hours.

Benefits

• FLSA Status Exempt
• Discretionary annual bonus
• Paid Time Off
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Paid Maternal Leave
• Parental Leave
• Learning reimbursement opportunities

The base salary range for this full-time position is $50,000-$65,000 + bonus + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.   

The Scion Group LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, creed, national origin, color, gender, sex, sexual orientation, gender identity or expression, age, physical or mental disability (as long as the employee/applicant is otherwise qualified for the job with or without a reasonable accommodation), genetic information, HIV/AIDS status, marital status, uniformed service, veteran status, pregnancy or other legally protected status or category under federal or state law. The Scion Group LLC complies with applicable state and local laws governing nondiscrimination in employment in all locations in which the Company has properties. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, training and other terms and conditions of employment. The Scion Group LLC is committed to the principles of equal employment opportunities.

IND-B  #wearehiring #werehiring

The Vision

At Okta, growth is our mandate, but a secure foundation is the prerequisite. In the Public Sector, this foundation is the bedrock of national security and citizen trust. As we scale, our focus is evolving beyond the "renewal transaction" toward a holistic strategy of Strategic Retention. We aren't just renewing contracts; we are securing the identity infrastructure of the US Federal Government and State & Local (SLED) agencies.

The Role

We are looking for a high-impact sales leader and strategic architect to lead our Public Sector Renewals team. As the Director, you are the steward of Okta’s largest and most complex public-interest partnerships.

In this role, you will lead a team of high-performing, individual contributor Renewals Managers. You will act as their coach, mentor, and lead strategist, navigating the unique procurement, regulatory, and budgetary landscapes of the Public Sector. You will be responsible for turning territory-level data into actionable retention playbooks, ensuring your team acts with precision, integrity, and long-term vision.

Core Responsibilities

1. Strategic Retention & Territory Architecture

• Segment Leadership: Own the retention strategy and execution for Okta’s Public Sector business, covering both US Federal and SLED markets.
• High-Value Deal Strategy: Act as the lead executive and strategic advisor for the segment’s most complex, high-stakes agreements, including those exceeding $5M+ in ARR.
• Predictive Intelligence: Move beyond basic forecasting to develop a deep, programmatic understanding of territory health, identifying risks early and designing "Path to Green" strategies that ensure long-term account stability.
• Retention Architect: Design and implement modern renewal playbooks that account for the unique cycles of public sector procurement, ensuring that our approach is proactive rather than reactive.

2. Leadership & Team Evolution

• The Leader as Coach: Manage and mentor a team of individual contributors, assisting them in navigating high-pressure negotiations and complex customer environments.
• Cultural Architect: Foster a culture of high accountability, integrity, and relentless customer focus. You will be responsible for recruiting, hiring, and developing the next generation of Public Sector renewal talent.
• Field Advocacy: Act as the voice of the Public Sector within the broader Renewals organization, ensuring that global processes are optimized for the nuances of government customers.

3. Diplomatic Power & Cross-Functional Partnership

• Sales Alignment: Partner as a peer to Public Sector Sales Leadership to ensure a unified strategy for account growth and retention.
• Government Affairs & Compliance: Collaborate closely with Government Affairs and Legal teams to stay ahead of regulatory shifts (e.g., FedRAMP) and procurement hurdles that impact our ability to retain and grow.
• Customer Success & Product Feedback: Drive a tight feedback loop with Customer Success and Product teams, ensuring that the "ground-level" reality of our government customers informs our long-term product and service roadmap.

Qualifications

• Experience: 10+ years in Renewals, Sales, or Account Management within the SaaS industry, with a minimum of 3-5 years in a high-performing leadership role.
• Public Sector Mastery: A proven track record of navigating US Federal and SLED procurement cycles, including experience with large-scale, $5M+ license agreements.
• Strategic Translator: The ability to take complex data sets and translate them into simple, winning tactics for the field.
• Negotiation Excellence: Expert-level negotiation skills with the ability to tactfully close high-value deals with a high degree of integrity and independence.
• Diplomatic Influence: Exceptional ability to partner cross-functionally with Sales, Customer Success, Product, and Government Affairs to drive collective outcomes.

Measures of Success

• Net Retention & ARR Growth: Achieve or exceed team goals for renewal rates and total ARR stabilization within the Public Sector.
• Operational Excellence: Maintain a highly accurate and predictable forecast for the segment.
• Talent Development: High engagement and performance scores from your team of Renewals Managers.

Cross-Functional Impact: Successful implementation of new retention playbooks that bridge the gap between Sales and Renewals.

#LI-Hybrd

#P25154_3426080

We are seeking a highly skilled and experienced Director of Health Economics and Outcomes Research (HEOR) with a strong focus on Oncology to join our team. The ideal candidate will play a critical role in leading and shaping the global HEOR and evidence strategy across both pipeline and launched oncology products to inform regulatory decision making and drive market access, reimbursement, and lifecycle value management globally.

This position involves working cross-functionally with Medical Affairs, Market Access, and Clinical Development to ensure alignment between evidence generation and strategic objectives. This role offers the opportunity to drive scientific leadership and innovation, developing new methodologies and evidence strategies to enhance the understanding of the value of oncology treatments and advance the organization’s mission of delivering life-changing therapies to patients worldwide.

Responsibilities:

• Execute integrated global HEOR strategies across pipeline and marketed oncology products, ensuring alignment with regulatory, market access, and reimbursement requirements across key geographies
• Contribute to and drive execution of end-to-end evidence generation plans across the product lifecycle, integrating clinical, economic, and real-world evidence to support value demonstration and access
• Execute and oversee the development of ex-US value Dossiers, ensuring alignment with clinical, economic, and epidemiologic evidence to support payer and HTA requirements
• Oversee the design and execution of real-world and observational studies (e.g., retrospective studies, prospective cohorts, registries) to generate evidence on effectiveness, safety, treatment patterns, and healthcare resource utilization
• Lead the development and adaptation of cost-effectiveness and budget impact models, ensuring alignment with global and local market access strategies and payer expectations
• Lead the design and execution of indirect treatment comparisons, external control analyses, and other comparative effectiveness approaches, ensuring methodological rigor and alignment with HTA expectations
• Oversee the development of systematic literature reviews and evidence syntheses to support HTA submissions, modeling inputs, and broader evidence strategies
• Provide strategic input into HTA submissions and payer engagement, ensuring that evidence packages address key uncertainties and support favorable reimbursement outcomes in global markets
• Drive innovation by advancing methodological approaches in health economics, epidemiology, and outcomes research, including novel frameworks to support value demonstration
• Identify and leverage appropriate real-world data sources (e.g., EHR, claims, registries) and establish external partnerships to support timely and high-quality evidence generation
• Develop and deliver clear, data-driven insights to internal leadership and external stakeholders, supporting alignment on the value proposition of oncology therapies
• Demonstrate strong leadership across cross-functional and cross-regional teams, fostering collaboration and driving high-quality, timely execution
• Uphold Corcept’s Key Principles by driving Collaboration, Embracing Possibility, Following the Data, and Leading by Doing, ensuring all initiatives align with the company’s ethics and patient-first mission

Preferred Skills, Qualifications and Technical Proficiencies:

• Proficiency in advanced statistical and modeling techniques for economic evaluation (e.g., Markov models, decision trees, cohort simulations)
• In-depth knowledge and ability to apply knowledge of US and global healthcare systems, global HTA requirements, and clinical development, to identify evidence gaps and formulate evidence generation and communication strategies
• Generate peer-reviewed publications to communicate study findings in scientific channels in alignment with the product publication strategy and the overall HEOR evidence generation strategy
• Expertise in the preparation and delivery of high-quality, evidence-based health economic reports and presentations to stakeholders at various levels (internal teams, HTA bodies, payers)
• Strong project management skills, with the ability to manage multiple priorities and deadlines
• Excellent communication and presentation skills

Preferred Education and Experience:

• Advanced degree (PhD, MSc, or equivalent) in health economics, public health, health policy, statistics, or a related field. A focus on oncology is highly desirable
• 10+ years of experience in HEOR, with a strong background in oncology
• Demonstrated ability to lead cross-functional initiatives and influence senior stakeholders
• Proven experience in global HEOR strategy, HTA submissions, and payer engagement
• Strong expertise in health economic modeling, RWE, and comparative effectiveness research
• Demonstrated expertise in indirect treatment comparisons, real-world evidence generation, and observational study designs (e.g., registries)
• Strong understanding of US & EU healthcare systems, reimbursement pathways, and payer requirements
• Strong communication and presentation skills, with the ability to translate complex data into actionable insights
• 15% with travel as required

The pay range that the Company reasonably expects to pay for this position is $209,100 - $276,800; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director, Medical Writing-Publications will provide strategic direction within the department and lead the successful development and tactical execution of publication plans across multiple programs in alignment with integrated evidence generation plans and lifecycle strategies and in compliance with SOPs, publication guidelines, and company goals. In addition, the Senior Director will be responsible for writing and coordinating the writing of peer-reviewed scientific publications, including distribution of work to medical writers or agencies as needed. They will serve as the primary contact for publication activities in collaboration with a cross‐functional group, including Clinical Development, Medical Affairs, Biometrics, Pharm/Tox, Research, and other relevant functions.  

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Lead key strategic initiatives within the department including publication strategy, planning, and execution of Ultragenyx products and pipeline publication plans, ensuring alignment with department and company goals. 
2. Provide leadership within the department by proposing and overseeing new initiatives and capabilities, such as establishing best practices for pubs strategy development and pull-through. 
3. Interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses and provide publication support and ensure compliant development of company-sponsored publications. 
4. Ensure smooth and effective document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving, journal and congress submissions).  
5. Liaise with relevant corporate functions and partner(s), as applicable, to ensure appropriate communication of publications‐related activities including manuscripts and congress abstracts/posters/presentations. 
6. Uses advanced communication and persuasion strategies to negotiate on behalf of their department or function on strategic matters. 
7. Contributes to strategic planning for the broader function and support high‐quality execution of Corporate‐wide initiatives. 
8. Acts as a trusted advisor and recognized technical expert. 
9. Manage and/or mentor junior medical writers and contractors. 
10. Support publication budget planning and management. 

Requirements:

1. BS, MS, or doctorate in a scientific or medical field. 
2. Solid experience (BS with >15 years or advanced degree with >10 years) in publication management and medical writing in the biotechnology/pharmaceutical industry preferred. 
3. Proven success with leading and managing medical writing agencies as well as track record for consistently meeting or exceeding quantitative targets. 
4. Demonstrated experience analyzing and communicating scientific data in peer-reviewed scientific publications; knowledge of applicable publications-related guidelines (i.e., ICMJE, GPP) and best practices, as well as legal, regulatory, compliance, and clinical/medical affairs. 
5. Experience writing and preparing manuscripts for publication in peer‐reviewed journals as well as abstracts, posters, and slide decks for presentation at scientific congresses. 
6. Successful and superior influencing skills across all levels of the organization and external collaborators. 
7. Exceptional oral and written communication skills. 
8. Experience in successfully engaging with cross‐functional product teams. 
9. Strong organizational abilities and experience in a multitasking environment. 
10. Motivated, self‐directed, and able to work autonomously and in team settings to meet aggressive organizational goals. 
11. Rare disease experience and a strong understanding of neurodevelopmental disorders are a plus. 

#LI-CS1 #LI-Hybrid, or #LI-Remote

Block is one company built from many blocks, all united by the same purpose of economic empowerment. The blocks that form our foundational teams — People, Finance, Counsel, Hardware, Information Security, Platform Infrastructure Engineering, and more — provide support and guidance at the corporate level. They work across business groups and around the globe, spanning time zones and disciplines to develop inclusive People policies, forecast finances, give legal counsel, safeguard systems, nurture new initiatives, and more. Every challenge creates possibilities, and we need different perspectives to see them all. Bring yours to Block.

The role This role sits at the intersection of policy and communications across Block and its brands. You will help define how Block shows up in public conversations about financial access and the future of money. You'll translate complex policy and regulatory developments into clear, credible narratives rooted in the experiences of our customers and sellers. You will help ensure Block speaks with a coherent, trusted voice across our brands Square and Cash App, as well as our broader ecosystem, especially in moments where technology and public trust converge.

You will

• Lead communications strategy across Block's policy and external affairs work to drive economic empowerment for our customers and sellers
• Partner closely with Policy, Legal, Risk, and other business teams to shape external narratives
• Ensure Block's policy positions are accurately and clearly reflected in external communications, particularly in high-visibility moments
• Advance Block's policy positions through ongoing engagement across channels, including media, digital platforms, and key industry forums
• Build and manage external engagement strategies, including media relationships, op-eds, editorial boards, as well as industry dialogues, and support broader corporate communications efforts, including high-priority company initiatives as needed
• Ensure Block's voice in policy conversations is clear, consistent, and trusted
• Translate complex regulatory issues into simple, durable narratives that resonate externally

You have

• Strategic storyteller and operator with a background in policy communications, public affairs, or issues-driven storytelling in a technology or regulated environment,
• A builder's mindset. We're actively rebuilding the tools, workflows, and playbooks of a modern communications function, and we want someone who sees friction in how work gets done and feels compelled to fix it.
• We welcome candidates from non-traditional backgrounds, with strong judgment and the ability to navigate complex, high-stakes external situations.
• Ability to translate dense policy topics into clear, human language and operate effectively across product, engineering, legal, and business teams,
• Excellent writing skills, experience engaging external stakeholders, and a proactive mindset focused on shaping narratives and building understanding, not just responding to events.

We're working to build a more inclusive economy where our customers have equal access to opportunity, and we strive to live by these same values in building our workplace. Block is an equal opportunity employer evaluating all employees and job applicants without regard to identity or any legally protected class. We will consider qualified applicants with arrest or conviction records for employment in accordance with state and local laws and “fair chance” ordinances.

We believe in being fair, and are committed to an inclusive interview experience, including providing reasonable accommodations to disabled applicants throughout the recruitment process. We encourage applicants to share any needed accommodations with their recruiter, who will treat these requests as confidentially as possible. Want to learn more about what we're doing to build a workplace that is fair and square? Check out our I+D page.

While there is no specific deadline to apply for this role, U.S. roles are typically open for an average of 55 days before being filled by a successful candidate. Please refer to the date listed at the top of this job page for when this role was first posted.

About the role:

We are seeking a Government Affairs Associate to join our Government Affairs team. This role will help drive the company's executive and legislative strategies, shape external messaging, and support engagements in Congressional and Executive branches. Duties will include track legislation, policy and regulatory developments related to autonomy, defense technology, and physical AI; help develop the company’s positions and responses, support political and stakeholder engagement strategy; and represent the company in meetings with policymakers and other key external audiences. The role will have the opportunity to develop internal management processes, lead strategy discussions, and engage with Applied stakeholders. 

At Applied Intuition, you will:

• Build and maintain relationships with Members of Congress and congressional staff on relevant Appropriations and Authorization Committees/Subcommittees.
• Help shape the company’s federal legislative priorities, policy positions, and political engagement strategy by understanding business objectives, growth opportunities, and potential risks.
• Work closely with Applied’s external government affairs consultants, trade associations, and industry partners to advance shared priorities.
• Draft legislative language, policy memoranda, briefing materials,  presentations, hearing testimony, and position papers.
• Support and manage the company’s political action committee with strong attention to detail for compliance and execution. 
• Partner with cross-functional leaders across the company to drive special projects and ensure timely, high-quality execution.

We’re looking for someone who has:

• 2-5 years of experience on Capitol Hill or in the executive branch, in policy and legislative analysis, or issue advocacy.
• Strong familiarity with the federal legislative process, including Appropriations and Authorization.
• Knowledge of autonomy, emerging technologies, and defense technology policy.
• Strong organizational skills and close attention to detail to operate effectively in a fast-paced environment.
• A demonstrated track record of strong execution and follow-through and results-driven mentality.
• A practical, team-oriented, and customer-centric mindset and a willingness to take on tasks at any level.
• A sense of humor.
• “Can-do” attitude–no task is too small.

Nice to have:

• Experience in Congressional engagement, advocacy, or political strategy. 
• Experience with PAC management or political campaigns and fundraising.
• Graduate degree with a focus on legislative process, technology, or defense.
• Technical background, particularly related to autonomy or artificial intelligence.
• Experience with the Google suite of tools in addition to AI tools for increased productivity.
• Active Security Clearance

Compensation at Applied Intuition for eligible roles includes base salary, equity, and benefits. Base salary is a single component of the total compensation package, which may also include equity in the form of options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

Applied Intuition pay ranges reflect the minimum and maximum intended target base salary for new hire salaries for the position. The actual base salary offered to a successful candidate will additionally be influenced by a variety of factors including experience, credentials & certifications, educational attainment, skill level requirements, interview performance, and the level and scope of the position.

Please reference the job posting subtitle for where this position will be located. For pay transparency purposes, the base salary range for this full-time position in the location listed is: $80,000 to $140,000 USD annually.

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Associate Director, GRA Global Labeling will be responsible for providing global labeling expertise and direction in support of the development, registration, and lifecycle management of innovative programs for rare diseases. This individual will liaise across key functional areas collecting critical regulatory milestones and developing detailed target label strategy plans during clinical development programs in order to align with company objectives and registration strategies. The responsibilities include managing labeling changes for lifecycle products, assisting in the development of labeling content for new products in pre-approval stages, and reviewing applicable regulatory documentation and artwork. The individual will also support implementation of approved labels which may include document control, QC/proofread, translations and verification of translations, and tracking project milestones and status. The individual must possess a thorough knowledge of global regulations and guidance governing drugs and biologics in all phases of clinical development. This position will report to Senior Director, GRA Global Labeling. 

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Provides global labeling leadership in support of the development, registration, and life-cycle management of Ultragenyx products for rare diseases. 

• Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market labels, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and other reference sources. 

• Demonstrate the ability to work in a matrix environment communicating label concepts and key messaging during label development consistent with program strategy and understanding and educating the impact to downstream activities (i.e., for commercial, and promotional educational purposes). 

• Build strong collaboration with key internal stakeholders, including Global Regulatory leadership team, Clinical Development, Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, Supply Chain, and other functions to support development of draft label text.  

• Interact with the cross functional labeling team (Label Working Group and Label Review Committee) to ensure timely implementation of global labeling changes in local product information that are consistent with the company’s position defined in the CCDS and in compliance with local labeling regulations. 

• Prepare, deliver and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input to provide high quality deliverables that meet regulatory standards, and corporate and program milestones. Facilitate LWG/LRC/SME meetings to develop content for label documents including resolution of complex label issues and ability to drive consensus utilizing current standard operating procedures, best practices and/or work instructions including work requests associated with partner companies and vendors. 

• Facilitate and lead target label strategies with cross functional labeling team incorporating key messaging aligned with target product profile and thorough understanding of competitive landscape environment. Provide necessary label output for HA interactions (i.e., FDA/EMA/PMDA/HC briefing book, scientific advice, and/or other key submission readiness milestones). 

• Manage approved labels in a document label management system to ensure accurate and up-to-date labeling is always available and accessible for global submissions and inspection readiness. 

• Contribute to the review and approval of artwork supporting global submissions. 

• Implement and maintain a quality control measure during all stages of label development. 

• Maintain knowledgebase of current global rules, regulations, and relevant guidance (draft or final) governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s).   

• Initiate or contribute to local and/or global process and/or system improvements which have a significant impact on business. 

Requirements:

• Minimum BA/BS degree in life sciences. Advanced degree preferred. 

• Strong scientific background with 8 years’ experience in the biotechnology and/or pharmaceutical industry including at least 4+ years in a global regulatory/labeling position. 

• Excellent attention to detail with solid coordinating, task planning and time management skills. 

• Excellent verbal, written and interpersonal communication skills. 

• Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability. 

• Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making in a collaborative way, and implementing plans and risk mitigation strategies. 

• Thorough understanding of global drug development regulations and guidelines. 
• Willingness to work in a dynamic, fast paced and changing corporate environment where roles and responsibilities are not well defined. 

#LI-CS1 #LI-Remote

About The Team:

At Archer, we are designing the future of flight. From unveiling our production aircraft, Midnight, to launching a defense-focused division in late 2024, our mission is to revolutionize urban air mobility and defense applications globally. We are a lean, fast-paced team that thrives on technical innovation, a "safety-first" culture, and a commitment to commercializing electric vertical take-off and landing (eVTOL) technology in the world’s busiest cities.

Our Government Affairs team is the bridge between Archer’s cutting-edge engineering and the federal policy landscape. We manage critical agency relationships across the DOT, FAA, and the White House. Our team ensures Archer remains at the forefront of the regulatory conversations that will define the next century of aviation.

What You’ll Do:

Archer is seeking a Federal Affairs Lead to serve as a key liaison on Capitol Hill. Based in Washington, D.C., you will be the "boots on the ground" responsible for navigating the complexities of the federal legislative environment. This is a junior to mid-level role designed for a self-starter who thrives in a high-autonomy environment—specifically our D.C. hub—and can navigate fast-paced environments.

You will report to Archer's Head of Government Affairs to ensure Archer’s mission is understood and supported by key policymakers.

• Shape the Future of Flight: Execute a high-impact federal strategy to architect the policy frameworks that will define the next century of Advanced Air Mobility.
• Champion Archer’s Mission: Build and cultivate influential partnerships across Capitol Hill, federal agencies, and industry associations to champion Archer’s vision and strategic priorities.
• Drive Strategic Intelligence: Act as the internal pulse on Washington, translating complex regulatory and policy shifts into actionable insights that steer our global business strategy.
• Be the Voice of Innovation: Represent Archer as a thought leader at premier D.C. events and member organizations, ensuring our voice is at the center of the conversation shaping the AAM industry.
• Craft Compelling Narratives: Develop high-stakes briefings and advocacy materials that simplify complex technologies into powerful, persuasive narratives for the nation’s top policymakers.
• Collaborate for Impact: Partner with internal innovators to bridge the gap between policy and technology, fostering a nimble, results-driven environment that moves at the speed of flight.

What You Need:

• Proven Track Record: 3+ years of impact within policy, regulatory, or government affairs—ideally forged on Capitol Hill—paired with a degree in Public Policy, Political Science, or a related field.
• Sector Sophistication: Familiarity with the federal landscape, specifically within transportation, aerospace, or emerging technology policy.
• Master Communicator: An exceptional ability to translate complex, cutting-edge technical concepts into clear, persuasive narratives for diverse, non-technical audiences.
• Relationship Architect: A natural at building and sustaining high-trust partnerships with Congressional staff, agency stakeholders, and key advocacy organizations.
• Analytical Rigor: A sharp eye for detail, with the ability to dissect complex policy documents and distill them into high-level, actionable business intelligence.
• Industry Edge: Prior exposure to Advanced Air Mobility (AAM) or aviation concepts is a significant advantage, but a passion for disrupting the status quo is a must.

Bonus Qualifications:

• Strategic thinker with a bias for action and results
• Comfortable balancing multiple priorities in a fast-paced environment
• Collaborative team player who thrives across time zones with diverse stakeholders

Please note that this job description is intended to provide a general overview of the position and does not include an exhaustive list of responsibilities and qualifications.

At Archer we aim to attract, retain, and motivate talent that possess the skills and leadership necessary to grow our business. We drive a pay-for-performance culture and reward performance that supports the Company’s business strategy. For this position we are targeting a base pay between $115,000 - $154,000. Actual compensation offered will be determined by factors such as job-related knowledge, skills, and experience.

Archer is committed to working with and providing reasonable accommodations to job applicants with physical or mental disabilities, and those with sincerely held religious beliefs. Applicants who may require reasonable accommodation for any part of the application or hiring process should provide their name and contact information to Archer’s People Team at people@archer.com. Reasonable accommodations will be determined on a case-by-case basis.

Who we are

Neros is a defense technology company rebuilding America’s drone industrial base. We design and manufacture high-performance unmanned systems that are tested in combat, iterated at startup speed, and built at massive scale. Our team culture is fast, hands-on, and obsessed with closing the gap between design and deployment.

As drones transform the character of warfare, Neros is delivering the systems the West needs to compete on the modern battlefield and deter the adversaries of democracy. We’re hiring engineers, operators, and builders who want to move fast, take on extreme ownership, and get capability into the hands of warfighters in months, not years.

What you will be doing

As the Government Affairs Associate, you would be responsible for assisting the Government team in navigating the complex budgetary, regulatory, and policy landscape that affects the company's operations and vision. This position will support identifying and providing analysis to leadership on the federal budget process. Additionally, the Government Affairs Associate should leverage existing relationships within the different branches of government. This position will have ownership of compliance related operations of the Neros PAC.

You should have the following

• 3+ years experience in monitoring federal strategy, or related fields
• Experience working in high-intensity environments
• Ability to work closely with leadership in rapid iteration cycles
• Exceptional communication skills with military and civilian stakeholders
• Knowledge of the U.S. defense ecosystem, including DoD procurement, Congressional appropriations, and national security policy
• Ability to translate complex technical issues into compelling policy narratives
• Understanding of Political Action Committees

Nice to have

• Prior government or military experience
• Proven track record monitoring DoD contracts
• Active TS/SCI clearance, or ability to obtain one
• Experience engaging with the government or military stakeholders

US Salary Range

$80,000 - $130,000 USD

The salary range for this role is an estimate based on a wide range of compensation factors, inclusive of base salary only. Actual salary may vary based on (but not limited to) work experience, education and/or training, critical skills, and/or business considerations. Highly competitive equity grants are considered part of Neros' total compensation package.

We’re an equal opportunity employer. We welcome all applicants without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

The Opportunity:

The Executive Director of GCP QA is a senior leadership role responsible for setting and executing the global GCP quality strategy across clinical development programs. This position ensures compliance with regulatory requirements, industry standards, and company policies governing clinical trials. The role provides strategic oversight of GCP QA activities, including leadership of a high-performing QA team, governance of contract research organizations, and advancement of continuous improvement initiatives to uphold the highest standards of quality and patient safety.

Serving as the GCP QA lead for late-stage clinical programs, this individual is accountable for GCP, GLP, and Pharmacovigilance/Safety oversight across multiple RevMed studies and represents QA in cross-functional and executive forums. The Executive Director will serve as a key advisor to senior leadership on clinical quality risk and regulatory readiness, helping to shape development strategy and enable successful regulatory outcomes. This position reports to the Vice President, Global Quality.

Key Responsibilities:

• Develop and execute the global GCP QA strategy aligned with corporate objectives, regulatory requirements, and RevMed SOPs.

• Serve as the Clinical QA Lead for global Phase 2/3 oncology studies, representing QA in governance forums and providing decision-making oversight on GCP related matters.

• Establish and maintain GCP QA frameworks, including policies, procedures, systems, and risk-based quality management (RBQM) to ensure compliance with global regulations (FDA, EMA, ICH).

• Provide end-to-end QA oversight of clinical studies, including:

• Review and approval of key study documents (protocols, monitoring plans, vendor oversight plans, quality agreements)

• Trial Master File (TMF) quality and inspection readiness

• GxP computerized systems and data integrity controls

• Lead and oversee GCP audit and inspection activities, including investigator sites, vendors, internal processes, and regulatory inspections (e.g., BIMO, PV), ensuring timely resolution of findings and CAPAs.

• Serve as the primary QA interface with global regulatory authorities, leading inspection strategy and representing the organization during health authority interactions.

• Drive global inspection readiness through structured planning, mock inspections, and cross-functional preparedness activities to support successful regulatory submissions and approvals.

• Oversee vendor and CRO quality management, including selection, qualification, governance models, performance monitoring (KPIs), and compliance with quality agreements.

• Proactively identify and mitigate systemic quality risks across the clinical portfolio, influencing development strategies and ensuring effective escalation to senior leadership.

• Monitor, trend, and report quality metrics (e.g., KPIs, QTLs, TMF health, CAPAs), leveraging insights to drive continuous improvement and operational excellence.

• Provide QA oversight of pharmacovigilance activities, ensuring compliance with safety reporting requirements and vendor performance expectations.

• Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Pharmacovigilance to drive quality, compliance, and continuous improvement.

• Drive innovation in QA through adoption of digital tools, advanced analytics, and modern risk-based quality approaches.

• Build, scale, and lead a high-performing global GCP QA organization, fostering a culture of quality, accountability, and operational excellence.

• Serve as a subject matter expert on GCP/GLP/PV regulations, advising senior leadership and influencing quality strategy across the organization.

Required Skills, Experience and Education:

• Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).

• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, including at least 10 years in GCP QA or clinical quality leadership roles, with demonstrated experience leading and hosting regulatory inspections (e.g., FDA BIMO, EMA, MHRA, PMDA).

• Demonstrated experience interacting directly with global health authorities and leading inspection strategy and execution.

• Experience supporting late-stage clinical development and regulatory submissions (e.g., NDA, MAA), preferably in oncology.

• Proven track record and relevant industry experience in leading GCP QA functions within a global organization, preferably in oncology.

• Strong knowledge of global GCP regulations, ICH guidelines, and clinical trial processes.

• Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels.

• Analytical thinker with a focus on continuous improvement and innovation.

• Experience working within outsourced clinical trial models and managing global CRO/vendor networks is highly desirable.

• This role may require occasional travel (up to 15%) for audits, inspections, and meetings.

• Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

Preferred Skills:

• Experience implementing advanced RBQM frameworks and leveraging analytics-driven approaches (e.g., centralized monitoring, signal detection) to enhance clinical quality oversight.

• Prior experience in a small-to-mid-size biotech environment, with demonstrated ability to build and scale QA functions within highly outsourced, global clinical development models. 

  #LI-Hybrid  #LI-GL1

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

Ultragenyx is seeking a dynamic and experienced physician to join the Gene Therapy Treatment Team. The physician will play a key medical affairs leadership role within the gene therapy portfolio, initially focused on GSDIa and MPS IIIA, where the company is in position to launch two gene therapies this year. This position will be instrumental in providing clinical and scientific education to gene therapy treating centers to ensure that patients receive their one-time therapy in the most effective manner and achieve their optimal therapeutic outcome.  

Reporting to the VP Global Medical Expert – Gene Therapies, the Executive Director is a senior medical affairs leader responsible for ensuring scientifically rigorous, compliant, and effective implementation of one-time gene therapies. The Executive Director will work closely with Medical Science Liaisons in the high-profile and innovative Gene Therapy Treatment Team through a largely externally facing role. The Executive Director also partners closely with Medical Affairs, Clinical Development, Regulatory, and Commercial leadership to enable successful launch and post launch adoption, while shaping external scientific dialogue around safety, durability, immunomodulation, and patient outcomes.   

The role requires extensive peer-to-peer interactions with external physicians providing gene therapy treatment in the commercial setting. The successful candidate will be comfortable working in a fast-paced intellectual environment, understand patient care including immunomodulation, and is able to work at the interface between clinical development and medical affairs leveraging their expertise to advance our mission to change the future of rare disease medicine. 

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Serve as a senior external medical leader for Ultragenyx gene therapies, leading compliant complex, scientific discussions with treating physicians  

• Enable successful implementation of gene therapies globally both within Ultragenyx and with external medical experts 

• Respond to inquiries and questions from treating sites with appropriate level of urgency 

• Lead the strategic and scientific requirements for educational materials and lead the delivery of training for the gene therapy treatment centers to ensure those centers are well prepared to manage patients throughout their gene therapy treatment journey 

• Provide expertise and contribute as needed to protocol development, steering committee meetings, data generation initiatives of Disease Monitoring Programs, and life-cycle management for label/indication expansion 

• Advise on strategic development of publications and medical materials that enable external medical engagement and address evidence gaps to inform clinical decision making 

• Work in partnership with VP, GME – Gene Therapies to develop and implement the global Gene Therapies Treatment Team Framework  

• Mentor and develop Global Medical Expert physicians and MSLs, helping build a scalable, high‑performing medical organization to support current and future gene therapy launches 

• Provide expertise and contribute as needed to key regulatory agency communications, including filings and information request responses 

• Represent Ultragenyx at key scientific and external stakeholder meetings to advance awareness and deep understanding of our science and therapies 

• As an expert, lead the education and training of Ultragenyx internal teams  

• Stay abreast of internal and external developments, trends and dynamics and provide direction for strategic implications to the development and commercialization of gene therapy  

Requirements:

• Medical Doctor (MD required, MD plus PhD preferred) with Board Certification (or equivalent) in Clinical Immunology, Clinical/Biochemical Genetics, Rheumatology or Neurology (required) 

• Academic/Faculty experience (+7 years) with a track record of high-quality publications   

• Pharmaceutical experience in drug development and clinical trials or Medical Affairs (+7 years) 

• Experience in the management of patients receiving systemic AAV gene therapy in the clinical trial and/or post FDA approval setting  

• Demonstrated ability to prioritize and lead complex post‑approval gene therapy activities, applying sound scientific judgment while enabling cross‑functional decision‑making 

• Demonstrated ability to lead through ambiguity and make strategic medical decisions in first‑ or best‑in‑class therapeutic settings 

• Availability for some out-of-hours work is an expectation 

• Demonstrated success working in a cross functional or multidisciplinary setting is essential 

• An established broad network of key experts and leaders within the rare disease community  
• Travel: 25-50% but may reduce with time as launches progress and team grows   

#LI-CS1 #LI-Remote

Join The Simtra Talent Community

Are you passionate about making an impact in the Contract Development and Manufacturing Organization (CDMO) industry? Even if you don’t see a current role that matches your skills and interests, we’d love to stay connected with you!

By joining our Talent Community, you'll be the first to know about exciting new opportunities across a wide range of roles within the CDMO industry, including areas like:

• Research and Development: Contribute to innovative solutions that drive progress.
• Manufacturing and Operations: Ensure high-quality production and efficiency.
• Quality Assurance and Regulatory Affairs: Maintain excellence and compliance.
• Project Management: Lead transformative projects from concept to completion.
• Business Development: Drive growth and foster meaningful partnerships.

As a valued member of our Talent Community, you'll receive:

• Early notifications of new job openings in the CDMO sector.
• Updates on company news and advancements.
• Exclusive insights into what it’s like to work with us.

We’re always looking for talented individuals who are eager to make a difference. Take the first step—join our Talent Community today—and let’s shape the future of the CDMO industry together!

Job Title: Associate Director, CMC Lead, Late-Stage Biologics      

Location: Remote OR Hybrid 3 days/week in office if located near Waltham, MA will be required.         

Role Overview: The Associate Director of CMC Leadership will provide technical and strategic leadership for late-stage CMC activities supporting the development, characterization, validation, licensure application, commercial readiness, and lifecycle management of biologics manufacturing process, with a focus on monoclonal antibodies. This role is a critical addition to our growing organization and is highly visible within the CMC team and across other functions. Serving as a matrix leader, this role will work closely with the CMC function leads in drug substance, drug product, analytical, and clinical supply chain. This role will also partner closely with Program Management, Quality, Regulatory Affairs, CDMOs, and consultants.

The ideal candidate is an established technical and matrix leader with hands-on technical experience in biologics process development and manufacturing support, and proven track record in leading cross-functional teams to achieve complex technical and regulatory milestones and bring late-stage biologics therapeutics to commercialization.

Key Responsibilities: 

• Oversee technical operations and lead strategy discussions for late-stage CMC activities including process characterization, PPQ, licensure application, regulatory inspection, and lifecycle management of monoclonal antibody therapeutics.
• Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports, in-process-control documents, process validation master plan, and BLA Module 3 sections.
• Lead CMC meetings and ensure drug substance, drug product, analytical, clinical supply chain, quality, program management, and regulatory affairs teams are aligned with overall CMC and program strategy.
• Maintain an effective action tracker for internal and external CMC deliverables. Adapt to changing priorities to ensure corporate CMC objectives are at the forefront.
• Facilitate problem solving, action planning, and decision making within the CMC team while keeping program level stakeholders informed at regular intervals.
• Foster a strong relationship with CDMOs and consultants. Ensure the external partners are fully aligned on Oruka strategy and goals.
• Liaise with internal and external stakeholders to support timely completion of technical. documents, batch records, campaign readiness, lot release, campaign reports, change controls, deviation investigations, and CAPAs.
• Partner with CDMO counterparts to oversee all CMC service, ensuring high quality work, timely delivery, and efficient meetings.
• Collaborate with manufacturing and clinical supply chain stakeholders to ensure robust clinical supply and distribution plans.
• Drive preparation and presentation of CMC content for internal and external meetings, facilitate cross-functional offsite workshops, and help organize business review meetings with CDMOs
• Support the diligence process and contract negotiation with new CDMOs and consultants.
• Work with program managers and Finance to track budgets, contracts, and change orders.
• 20-25% travel in support of diligence process, strategy discussion meetings, and activity supervision at CDMOs.

Qualifications:

• Master’s or PhD in relevant disciplines with 10+ (MS) or 7+ (PhD) years of experience in biologics CMC functions including upstream, downstream, analytical, and drug product.
• Must have experience leading late- and commercial-stage CMC activities including process characterization, PPQ, BLA, regulatory inspections, life cycle management, and post approval submissions.
• Prior matrix leadership experience is highly preferrable. Have led cross-functional CMC teams to drive strategy alignment on risk mitigation, resource planning, process validation, regulatory filing, and post approval changes.
• Experience with pre-filled syringe and/or auto-injector is a plus.
• Strong program management skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets.
• In-depth knowledge of CMC quality and regulatory requirements in support of global regulatory filings
• Experience with managing CDMOs. Demonstrated track record of successful tech transfers to commercial CDMOs
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
• Strong sense of urgency and ability to direct the CMC team towards their deliverables in a highly fast paced environment

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA -OR-remotely, is $182,000 to $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Follows guidance from the senior leader to deliver and implement customer training and support. Performs virtual and onsite visits for imaging site support. Denver, Los Angeles, or Dallas based. 

Responsibilities

• Communicates with imaging partners to increase efficiency and quality of performed scans through education of CCTA best practices for: patient preparation, acquisition, reconstruction, and heart rate control;
• Performs virtual and onsite support events with our imaging partners;
• Organizes and leads training events
• Attends or reviews recording/AI Companion notes for all assigned meetings;
• Reports and documents all related concerns and recommended process improvements to imaging sites and leadership;
• Demonstrates Cleerly software;
• Collaborates with other departments and CT vendors to standardize best practices for image quality and workflow efficiency.
• In person (25% - 50% required travel);
• Travel within the US and International;
• In virtual meetings (50% - 75%);

Required Competencies

• ARRT (CT) required;
• Minimum level of education is an associate degree in radiologic technology or equivalent;
• 2+ years Coronary CTA experience;
• Basic Computer Software Knowledge.

Soft Skills            

• Communication: Clear, concise communication to convey plans and initiatives to team members and stakeholders;
• Critical thinking: evaluate various planning scenarios, anticipate challenges;
• Adaptability: adjust plans in response to unexpected developments;
• Coachability - willingness to Learn;
• Collaboration: cross-functional projects;

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 10% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $103,000 - $108,000
• TTC: $113,300 - $118,800

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.